BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY DISECTING GRASPING FORCEP

    MDR report key: 34979 · Received July 19, 1996

    Report

    Report Number
    34979
    Event Type
    Injury
    Date Received
    July 19, 1996
    Date of Event
    July 3, 1996
    Report Date
    July 19, 1996
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE LAPAROSCOPIC HERNIA REPAIR SURGERY WAS TAKING PLACE THE DR NOTICED A BLACK CONE SHAPED PIECE OF RUBBER IN THE ABDOMINAL CAVITY. THE DR WAS ABLE TO RETRIEVE THE OBJECT AND REMOVE IT FROM THE ABDOMINAL. THE CONE SHAPED OBJECT CAME FROM THE PRODUCT WHERE THE ARM MEETS THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY DISECTING GRASPING FORCEP DISECTING GRASPING FORCEP GCJ KARL STORZ ENDOSCOPY AMERICA, INC. 28090 K J NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention