BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3223164 · Received July 12, 2013

    Report

    Report Number
    2955842-2013-02534
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 14, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE BLACK TUBE INSULATION WAS DAMAGED BELOW THE MIDPOINT. THE INSULATION WAS GOUGED ON ONE SIDE AND HAS A .210 X .105 PIECE MISSING ROUGHLY 6 ABOVE THE SNAKE WRIST. THE TUBE HAD OTHER AREAS BELOW THIS DAMAGE WITH INSULATION LIFTED UP. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE THE BOWEL GRASPER INSTRUMENT INSULATION WAS OBSERVED TO BE RUBBED OFF. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    324088 BOWEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-04 S10121210 240

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM, INSTRUMENTS & ACCESSORIES