BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16944091 · Received May 17, 2023

    Report

    Report Number
    2955842-2023-13682
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED/CONFIRMED THE REPORTED EVENT. THE CLIP APPLIER INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP (E.G., THE INSTRUMENT PASSES ENGAGEMENT AND ABLE TO RETAIN CLIP THROUGH ENGAGEMENT BUT CANNOT APPLY THE CLIP). COMMON CAUSES OF LOSS OF FUNCTIONALITY TO APPLY A CLIP IS ATTRIBUTED TO EITHER A DAMAGED GRIP CABLE OR MISALIGNED GRIPS. THE CLIP APPLIER INSTRUMENT WAS FOUND WITH ONE GRIP BENT. THE DAMAGE WAS FOUND NEAR THE TOP OF THE CLIP GROOVE, CAUSING AN OFFSET AT THE TIPS. AS A RESULT, THE CLIP COULD NOT BE PROPERLY RELEASED FROM THE GRIPS. COMMON CAUSES OF THE FAILURE MODE BENT-SEVERELY INSTRUMENT GRIPS-TIPS ARE TYPICALLY ATTRIBUTED TO THE USER, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. SEVERELY BENT GRIPS ARE ATTRIBUTED TO DAMAGE DURING EITHER USE OR REPROCESSING, AS SEVERE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO ACCIDENTAL DROPS, INCORRECT INSTRUMENT TRAY OR SINK SIZES FOR REPROCESSING, OR OVERLOADING THE TIPS.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIPS NOT FIRING PROPERLY, AN INVESTIGATION IS IN PROGRESS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT HAS NOT YET BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT YET BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: PER THE DESCRIPTION OF THE COMPLAINT, THE CLIP APPLIER MAY HAVE INCURRED A FAILURE MODE THAT IS KNOWN TO IMPACT CLIP APPLICATION EFFECTIVENESS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGICAL SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS USED WITH THE GREEN HEM-O-LOK MEDIUM-LARGE WECK CLIPS. THE CLIPS WOULD NOT STAY ON THE TISSUE. THE TISSUE BUNDLE WAS NOT GREATER THAN 10MM. THE SURGEON COMPLETED THE SURGICAL TASK WITH A NEW CLIP APPLIER INSTRUMENT. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY REPORTED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584585 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K10220221 0337 00886874112465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.