BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH

    MDR report key: 4091458 · Received July 24, 2014

    Report

    Report Number
    4091458
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE HOT SCISSORS, THE WAVY CLAMP USED TO RETRACT APPEARED TO BEGIN TO CAUTERIZE AT THEIR LOCATION ON THE TISSUE RATHER THAN THE LOCATION OF THE HOT SCISSORS. DOCTOR BELIEVED TO BE SHORT EITHER IN THE HOT SCISSORS OR THE CORD. STRYKER DISP MONOPOLAR CABLE REF: 0250-040-012 EXP 2015-02 USED & SAVED FOR INSPECTION IN ADDITION. DR NOTED A PARTIAL THICKNESS BURN ON PT'S ABDOMEN WHILE APPLYING DERMABOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433046 ENDOPATH ELECTROSURGICAL, CUTTING AND COAGULATION GEI ETHICON ENDO-SURGERY, INC 5DCS L4EL67

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR