BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASPER

    MDR report key: 2061311 · Received April 12, 2011

    Report

    Report Number
    MW5020259
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MARINA MEDICAL
    Product Code
    HTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED GRASPER INTO PORT AND TWO PIECES OF PLASTIC FELL INTO ABDOMINAL CAVITY. PHYSICIAN RETRIEVED THE LARGER PIECE, BUT UNABLE TO FIND SMALLER PIECE. SURGEON DETERMINED RISK OF TO RETRIEVE OUT WEIGHED RISK OF LEAVING IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GASPER GRASPER HTD MARINA MEDICAL 13-1381ADG

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability