BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15564759 · Received October 7, 2022

    Report

    Report Number
    2955842-2022-14460
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 8, 2022
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE HAS RECEIVED THE MEDIUM- LARGE CLIP APPLIER INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE CLIP TEST WAS PERFORMED THREE TIMES AND PASSED. NO DAMAGE WAS FOUND. THE INSTRUMENT MOVED AS EXPECTED WHEN MANUALLY ARTICULATED. THE INSTRUMENT WAS FULLY FUNCTIONAL. A REVIEW OF THE INSTRUMENT LOG FOR THE MEDIUM- LARGE CLIP APPLIER INSTRUMENT (470327-12/N10210830 0051) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6)2022. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE CLIP APPLIER INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM- LARGE CLIP APPLIER INSTRUMENT FAILED THE MANUAL SELF-TEST DURING THE "YAW MOVEMENT" AND THE JAWS SWAYED TO THE SIDE INSTEAD OF COMING TOGETHER EQUALLY WHEN CLOSING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE SURGERY WAS COMPLETED WITH ANOTHER CLIP APPLIER. THE CUSTOMER CONFIRMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE CUSTOMER EXPLAINED THAT THE MOTION OBSERVED WAS THAT THE CLIP APPLIER MANUAL SELF-TEST THE INSTRUMENT FAILED AND THE JAW SWAYED TO THE SIDE INSTEAD OF COMING TOGETHER EQUALLY WHEN CLOSING. THE CUSTOMER STATED THE ISSUE HAPPENED ONCE AND THEY REMOVED THE INSTRUMENT AND REPLACED WITH A NEW CLIP APPLIER. THE CUSTOMER DID NOT USE IT AGAIN. THE DRAPE WAS NOT EXCHANGED AND IS NOT AVAILABLE FOR RETURN. THE CUSTOMER STATED THE INSTRUMENT WAS RETURNED. THERE ARE NO IMAGES OR VIDEOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271855 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 N10210830 0051 00886874112465

    Patients

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