BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLE MEDICAL CORP. MARLBORO, MASS.

    MDR report key: 563849 · Received November 5, 2004

    Report

    Report Number
    MW1034129
    Event Type
    Malfunction
    Date Received
    November 5, 2004
    Date of Event
    July 23, 2004
    Report Date
    November 5, 2004
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON DOING LOOP ELECTRODE EXCISIONAL PROCEDURE, INSERTED DEVICE TIP -CONNECTED TO ELECTROCAUTERY UNIT- INTO VAGINA AND PRESSED ACTIVATE BUTTON, WIRE IMMEDIATELY POPPED. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLE MEDICAL CORP. MARLBORO, MASS. FISCHER CONE BIOPSY EXCISOR HGI HARMAC MEDICAL PRODUCTS, INC. * D 201707

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other