INTUITIVE SURGICAL, INC.

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restrict…

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain activ…

Access Port System tray may develop cracks potentially resulting in a sterility breach.

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and m…

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally in…

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to…

There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bo…

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause t…

Potential staple deployment failure and device fragment generation

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released w…

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical seve…

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If th…

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperativ…

Incorrect expiration date on its package labeling (shipper box and inner carton label).

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully…

Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may ca…

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure…

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preven…

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or…

One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating…

During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential …

This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially in…

Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also…

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.

Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured …

da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.

Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances

An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend

Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.

Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact …

This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in uninte…

B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.

In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.

Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.

The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.

There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.

Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.

Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.

The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.

Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.

Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..

In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was …

Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.

Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.

Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use …

Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.

Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the …

Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.

A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indicat…

Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.

Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.

Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injur…

Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.

Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.

There is potential for the sterility of the product to be compromised.

Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.

Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.

Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.

Clarification of existing labeling information and operating procedures.

Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.