BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESCULAP PRESTIGE GRASPER

    MDR report key: 6215321 · Received December 28, 2016

    Report

    Report Number
    MW5066984
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    August 11, 2016
    Report Date
    December 28, 2016
    Manufacturer
    AESCULAP, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, ONE SIDE OF THE JAWS OF A LAPAROSCOPIC PRESTIGE GRASPER BROKE OFF INSIDE THE PATIENT'S ABDOMEN DURING A LAPAROSCOPIC APPENDECTOMY/CHOLECYSTECTOMY. ALL PIECES OF THE BROKEN INSTRUMENT WERE REMOVED FROM THE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861601 AESCULAP PRESTIGE GRASPER AESCULAP PRESTIGE GRASPER GCJ AESCULAP, INC. 8360-10

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR