BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3971930 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04652
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 3, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS INSPECTED THE INSTRUMENT AND OBSERVED THAT THE BLADE WAS DISLODGED BETWEEN THE GRIPS. THE INSTRUMENT DID NOT PASS THE SELF-TEST NOR ENGAGE. THE BLADE CABLE NOR BLADE WAS BENT. THE INSTRUMENT WAS RESEATED AND THE PASSED THE SELF-TEST AND NO ERROR MESSAGES WERE FOUND. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. CAUTERY AND SEAL FUNCTION TESTING WERE PERFORMED WITH NO ISSUES WERE FOUND. GRIP FORCE TESTING WAS PERFORMED AND ALL READINGS WERE ABOVE MINIMUM REQUIREMENTS. THE GAPS BETWEEN THE GRIPS WERE FOUND TO BE WITHIN NORMAL RANGE. FAILURE ANALYSIS ALSO OBSERVED THAT THE SNAKE WRIST WAS DISLODGED. NO PIECES WERE MISSING. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM BUT WOULD NOT ADVANCE THROUGH AN 8MM CANNULA DUE TO THE DISLODGED SNAKE WRIST. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DISLODGED SNAKE WRIST, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VESSEL SEALER INSTRUMENT DID NOT SEAL DURING A DA VINCI HYSTERECTOMY PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446489 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10140226 951

    Patients

    Seq Age Sex Outcome Treatment
    1