BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL LOOP ELECTRODE

    MDR report key: 34294 · Received July 19, 1996

    Report

    Report Number
    MW1009537
    Event Type
    Other
    Date Received
    July 19, 1996
    Date of Event
    April 11, 1996
    Report Date
    July 11, 1996
    Manufacturer
    UTAH MEEICAL PRODUCTS, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOOPS DID NOT CUT CLEANLY THROUGH THE TISSUE, BUT APPEARED TO DRAG AS WELL AS SOME ARCING WHICH CAUSED BURN. CAUTERIZED TO ASSURE HEMOSTASIS. NO BLEEDING. ADD'L LOT #: 52087-1, 54174-1, 52811-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL LOOP ELECTRODE ELECTROSURGICAL LOOP ELECTRODE JOS UTAH MEEICAL PRODUCTS, INC. DLPB11, DLPM11, DLPS11

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other