BEUDAMED
    FDA Adverse Event Other Summary report: N

    WISAP

    MDR report key: 1124394 · Received August 14, 2008

    Report

    Report Number
    MW5007998
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 14, 2008
    Manufacturer
    GESELLSCHAFT FUR WISSENSCHAFTLICHEN APPARATEBAU MBH
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP OF ONE OF THE BLADES OF THE HOOK SCISSOR BROKE OFF AND WAS NOT ABLE TO BE RETRIEVED FROM INSIDE THE PT. PT AND FAMILY WERE INFORMED OF THE EVENT. HEALTHCARE TEAM WITH INVOLVEMENT OF PT AND FAMILY DECIDED NOT TO RE-OPERATE AT THIS TIME. WE DETERMINED THE DEVICE TO BE APPROX 10 YEARS OLD AND DO NOT HAVE RECORDS AS TO THE MODEL OR LOT NUMBER. THE NUMBERS HER REFLECT THE SIMILAR REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WISAP HOOK SCISSOR (INSULATED) LRW GESELLSCHAFT FUR WISSENSCHAFTLICHEN APPARATEBAU MBH 7320 HE 340MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other