BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEISGANG MEDICAL INC

    MDR report key: 752509 · Received May 25, 2005

    Report

    Report Number
    MW1035489
    Event Type
    Other
    Date Received
    May 25, 2005
    Date of Event
    May 4, 2005
    Report Date
    May 9, 2005
    Manufacturer
    *
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HALF WAY THROUGH A LOOP ELECTRICAL EXCISION PROCEDURE FOR CERVICAL DYSPLASIA THE PT RECEIVED AN ELECTRIC SHOCK ON THE LEG WHERE THE GROUDING PAD WAS. THIS RECURRED AFTER CHANGING THE GROUNDING PAD. I THEN PLACED ANOTHER GROUNDING PAD ON MYSELF AND USING THE SAME BOVIE ON MYSELF, CONFIRMED THE ELECTRIC SHOCK. THE CONNECTING CORD BETWEEN GROUNDING PAD AND MACHINE HAD BEEN REPLACED IMMEDIATELY AFTER PURCHASING THIS USED MACHINE, FOR THE VERY SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEISGANG MEDICAL INC ELECTROSURGICAL GENERATOR GEI * LM90 *
    2 MACROLYTE DUAL DISPERSIVE ELECTRODE ELECTROSURGICAL GENERATOR GEI CON MED CORP. 3Q96 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other