BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3971917 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04651
    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 WITH HEAVY BIODEBRIS. THE INSTRUMENT DID NOT PASS THE SELF-TEST AND WOULD NOT ENGAGE. THE BLADE CABLE NOR THE BLADE WERE BENT. THE BLADE WAS RESEATED AND THE INSTRUMENT PASSED SELF-TEST WITH NO ERROR MESSAGES. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. CAUTERY AND SEAL FUNCTION TESTING WERE PERFORMED AND NO ISSUES WERE FOUND. GRIP FORCE TESTING WAS PERFORMED AND ALL READINGS WERE ABOVE THE MINIMUM REQUIREMENTS. THE GAP BETWEEN THE GRIPS WAS FOUND TO BE WITHIN NORMAL RANGE. ENGINEERING ANALYSIS OBSERVED THAT A CONDUCTOR WIRE WAS FOUND WITH DAMAGE TO THE INSULATION COATING AT TWO DIFFERENT LOCATIONS. THE FIRST LOCATION HAD A PIECE STICKING OUT WITH THE METAL WIRE SHOWING BUT NO MATERIAL WAS MISSING, THE PIECE COVERED THE EXPOSED AREA. THE SECOND LOCATION HAD A SMALL PIECE MISSING. THE DAMAGE TO THE WIRE LIKELY OCCURRED FROM MAKING CONTACT WITH ANOTHER OBJECT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGED CONDUCTOR WIRE WITH MATERIAL MISSING, 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
    446950 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10140226 979

    Patients

    Seq Age Sex Outcome Treatment
    1