BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ DEBAKEY

    MDR report key: 1911515 · Received November 19, 2010

    Report

    Report Number
    1911515
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 10, 2010
    Report Date
    November 19, 2010
    Manufacturer
    KARL STORZ
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    THEY PHYSICIAN INSERTED THE GRASPING FORCEPS INTO LAPAROSCOPIC PORT AND NOTED THAT THE INSULATION COATING WAS MISSING. COATING FOUND IN WOUND AND RETRIEVED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN, BUT THIS DOES HAPPEN AT TIMES====================== MANUFACTURER RESPONSE FOR LAPARSCOPIC FORCEP, KARL STORZ DEBAKEY======================THE MANUFACTURER WILL RECOAT THE INSTRUMENT AND RETURN TO THE HOSPITAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ DEBAKEY LAPAROSCOPIC FORCEPS GCJ KARL STORZ * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO OTHER THERAPIES