BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17727427 · Received September 12, 2023

    Report

    Report Number
    2955842-2023-18387
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 16, 2023
    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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT AND COMPLETED THE FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS PLACED ON THE IN-HOUSE SYSTEM AND PASSED INITIALIZATION. THE INSTRUMENT EXHIBITED UNINTUITIVE MOTION. REVERSED MOTION WAS OBSERVED. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT SWIPE TESTS. THE INSTRUMENT WAS RETURNED WITH THE ENERGY CORD CUT, SO THE CUT AND ENERGY DELIVERY TESTS WERE UNABLE TO BE PERFORMED. NO FAILURES WERE OBSERVED DURING LOG REVIEW. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED MAIN TUBE. IT WAS FOUND THAT THE MAIN TUBE CAN BE ROLLED PAST THE HARD STOP IN THE ROLL GEAR (ROLL GEAR TABS) WITH LITTLE RESISTANCE, IN BOTH ROLL DIRECTIONS. THIS INDICATES THAT THE ROLL GEAR TABS ARE DAMAGED. SINCE THE HARD STOP IS DAMAGED, THE MAIN TUBE CAN ROTATE INDEPENDENTLY OF THE ROLL GEAR, CAUSING MISCALIBRATION BETWEEN THE MASTER TOOL MANIPULATOR (MTM) AND TUBE, AND CREATING NON-INTUITIVE MOVEMENT OF THE DISTAL TIP. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION OF THE INSTRUMENT FOUND SCRATCH MARKS ON THE GRIP TIPS. NO MATERIAL APPEARS TO BE MISSING.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE VSE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION.

    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 SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) EXPERIENCED COUNTERINTUITIVE MOVEMENT. SEVERAL TROUBLESHOOTING EXERCISES WERE PERFORMED. A BACKUP VSE WAS USED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DEVICE WAS NOT INSPECTED PRIOR TO USE. THE ISSUE OCCURRED WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON SIDE CONSOLE (SSC) HIGH-RESOLUTION STEREO VIEWER (HRSV) WHILE ATTEMPTING TO MANIPULATE INSTRUMENTS. THE FAILURE WAS NOT RELATED TO THE INABILITY TO MOVE THE INSTRUMENT AT ALL BUT RATHER THE INSTRUMENT WRIST MOVED UP WHEN IT SHOULD HAVE MOVED DOWN AND LEFT WHEN IT SHOULD HAVE GONE RIGHT. THE SCALE WAS CORRECT, BUT THE DIRECTION WAS OFF. THE INSTRUMENT DID NOT MOVE IN THE CORRECT DIRECTION. THE TIMING OF THE INSTRUMENT WAS CORRECT. THERE WAS NO SHAKINESS/FRICTION OBSERVED. THERE WAS NO INSTRUMENT-INSTRUMENT OR ARM-ARM INTERFERENCE. THERE WERE NO COLLISIONS THAT THE STAFF WAS AWARE OF. THE INSTRUMENT WORKED CORRECTLY FOR APPROXIMATELY 3 HOURS BEFORE THE ISSUE OCCURRED. THE CUSTOMER TRIED RESEATING THE INSTRUMENT ON THE ARM, RESEATED THE DRAPE CALIBRATION, AND TRIED ANOTHER INSTRUMENT ON THE ARM (WHICH WORKED FINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232185 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L83230316 0332 10886874115661

    Patients

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