BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ

    MDR report key: 17318 · Received September 2, 1994

    Report

    Report Number
    17318
    Event Type
    Injury
    Date Received
    September 2, 1994
    Date of Event
    June 14, 1994
    Report Date
    September 2, 1994
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FFY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAUTERY UNIT DISCHARGED CURRENT IMMEDIATELY UPON HOOK UP OF POWER CABLE TO ENDO-SHEARS. APPEARS CAUSE WAS MFR'S CABLE. CABLE HAS SCREW-ON HOUSING WHICH WAS LOOSE AND WHEN CONNECTED TO THE CAUTERY'S UNIPOLAR CHANNEL, THE UNIT WAS ACTIVATED WITHOUT USING THE FOOT PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ CABLE FFY KARL STORZ ENDOSCOPY-AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization