BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3113330 · Received May 26, 2006

    Report

    Report Number
    2020550-2006-00032
    Event Type
    Malfunction
    Date Received
    May 26, 2006
    Date of Event
    April 21, 2006
    Report Date
    May 26, 2006
    Manufacturer
    KARL STORZ GMBH AND CO. KG
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH WHEN ONE JAW BROKE OFF INSTRUMENT INTO PATIENT. DOCTOR RETRIEVED BROKEN PIECE IMMEDIATELY AND WENT ON TO COMPLETE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO PATIENT AND PATIENT CONDITION POST-OP WAS FINE. PLEASE REFER MFR REPORT # 9610617-2006-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ BOWEL GRASPER KOG KARL STORZ GMBH AND CO. KG 33410C IG

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other