BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15859235 · Received November 23, 2022

    Report

    Report Number
    2955842-2022-15491
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    September 10, 2022
    Report Date
    October 26, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS (MBF) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRMED THE REPORTED COMPLAINT OF RECOGNITION FAILURE. THE MBF INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE MBF INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE RECOGNITION TEST WAS PERFORMED A TOTAL OF THREE TIMES AND PASSED. THE MBF INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE MBF INSTRUMENT WAS FULLY FUNCTIONAL. A REVIEW OF THE ERROR LOGS SHOWED NO ERRORS. ADDITIONAL OBSERVATIONS, WHICH WERE NOT REPORTED BY SITE AND WERE NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT, WERE THE FOLLOWING: THE LIFE INDICATOR OF THE MBF INSTRUMENT FAILED TO ROTATE. THE HOUSING WAS REMOVED AND FOUND THE LIFE INDICATOR DID NOT ROTATE WHEN THE MBF INSTRUMENT EXPIRED. A REVIEW OF THE LOG SHOWED THAT THE INSTRUMENT HAD NO LIVES REMAINING AND EXPIRED. THE MBF INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY. THE MBF INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE ROOT CAUSE OF THIS FAILURE WAS TYPICALLY ATTRIBUTED TO MISHANDLING OR MISUSE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. A REVIEW OF THE DEVICE LOGS FOR THE MARYLAND BIPOLAR FORCEPS ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE MARYLAND BIPOLAR FORCEPS WAS LAST USED ON (B)(6) 2022 VIA SYSTEM (B)(4). THERE WERE 0 USE REMAINING AFTER THIS LAST USAGE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS FOUND THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY OF THE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE WAS TYPICALLY ATTRIBUTED TO MISHANDLING OR MISUSE. 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 SURGICAL PROCEDURE, RECOGNITION FAILURE ISSUE OCCURRED ON THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT. THE INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MBF WAS CHECKED PRIOR TO USE WITH NO ISSUE. THE MBF WAS BROKEN WHEN THE PROCEDURE WAS STARTED. THE CUSTOMER CONTINUED THE PROCEDURE WITH ANOTHER INSTRUMENT. THE MBF DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL. NO ARCING WAS OBSERVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897527 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 K10210830 0190 00886874112281

    Patients

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