BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORSON NEEDLE FOR ESU DISCRETION

    MDR report key: 86551 · Received August 2, 1994

    Report

    Report Number
    86551
    Event Type
    Other
    Date Received
    August 2, 1994
    Date of Event
    March 8, 1994
    Report Date
    March 11, 1994
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ELECTROSURGICAL NEEDLE; INSULATION BROKE DOWN AT BALL, CAUSING THE HOLDER TO BECOME ENERGIZED SHORTLY AFTER THE START OF CASE. SURGEON RECEIVED BURN ON HAND THROUGH GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORSON NEEDLE FOR ESU DISCRETION ESU PROBE GEI KARL STORZ ENDOSCOPY * 6684

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other VALLEY LAB ESU FORCE 4