BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM PK DISSECTING FORCEP 8MM

    MDR report key: 3111646 · Received May 7, 2013

    Report

    Report Number
    MW5030124
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 7, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) UNDERWENT THE FOLLOWING SURGICAL PROCEDURE - ROBOT-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY AND LAPAROSCOPIC APPENDECTOMY. THE PK DA VINCI DISSECTING FORCEP GRASPER PORTION OF THE INSTRUMENT BROKE ON THE JAW OF THE GRASPER AND ONE SIDE OF THE GRASPER FELL FREE INTO THE ABDOMEN. THE 1CM X 5MM PIECE WAS SUCCESSFULLY RETRIEVED. A POSTOPERATIVE ABDOMINAL X-RAY WAS PERFORMED TO CONFIRM FOREIGN BODY WAS REMOVED COMPLETELY. THIS DEVICE WAS ON ITS 1ST OF TEN "LIVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199869 DA VINCI SI SURGICAL SYSTEM PK DISSECTING FORCEP 8MM PK DISSECTING FORCEP NAY INTUITIVE SURGICAL, INC. M10120830123

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR