BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE

    MDR report key: 2163436 · Received July 1, 2011

    Report

    Report Number
    2163436
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AESCULAP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO SURGERY STAFF, THE GRASPER FELL APART WHEN SURGEON WAS TRYING TO USE IT ON THE PATIENT WHILE ATTEMPTING TO TAKE DOWN ADHESIONS DURING ABDOMINAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE ATRAUMATIC LOCKING GRASPER GCJ AESCULAP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR