BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15526097 · Received October 1, 2022

    Report

    Report Number
    2955842-2022-14332
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) COULD NOT CONFIRM NOR REPLICATE THE REPORTED COMPLAINT. FA FOUND THE INSTRUMENT TO HAVE ONE LIFE REMAINING. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS MULTIPLE TIMES. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED CUT AND ENERGY DELIVERY TESTS. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT SWIPE TESTS. THE HOUSING WAS REMOVED AND NO DAMAGE TO THE RADIO FREQUENCY IDENTIFIER (RFID) TAG WAS OBSERVED. NO LOGS ARE AVAILABLE FOR REVIEW AT THIS TIME. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. AN INSTRUMENT LOG FOR THE VESSEL SEALER EXTEND INSTRUMENT (PART # 480422-01 / BATCH # L11220704-0087) COULD NOT BE PERFORMED SINCE THE INSTRUMENT WAS NOT USED AND STILL HAS 1 LIFE REMAINING. THIS IS A SINGLE USE INSTRUMENT. ADDITIONAL LOG REVIEWS CONFIRMED SYSTEM SK3318 WAS USED ON 30-AUG-2022 FOR A 5 HOUR AND 41 MINUTE LOW ANTERIOR RESECTION PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SURGICAL PROCEDURE WAS DELAYED BY GREATER THAN 31 MINUTES WITH A TOTAL OPERATIVE TIME OF 341 MINUTES. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) PERFORMED ADDITIONAL ANALYSIS ON THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. THE INITIAL FAILURE ANALYSIS FINDINGS WERE CONFIRMED. THE VSE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION, ENGAGEMENT, INTUITIVE MOTION, AND ENERGY DELIVERY TESTS. NO ADVANCED LOGS WERE AVAILABLE FOR THIS INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A VESSEL SEALER EXTEND INSTRUMENT WAS INSERTED AND NOT RECOGNIZED ON THE ARM. THERE WAS NO NOISE OR LIGHT WHEN INSERTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT IT TOOK ABOUT 10 MINUTES TO SWITCH THE INSTRUMENTS; HOWEVER, THE PROCEDURE WAS DELAYED OVER 30 MINUTES DUE TO TROUBLESHOOTING AND SWITCHING THE ARMS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479510 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L11220704 0087 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.