BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISCHER

    MDR report key: 549776 · Received July 27, 2004

    Report

    Report Number
    MW1032836
    Event Type
    Injury
    Date Received
    July 27, 2004
    Date of Event
    July 14, 2004
    Report Date
    July 27, 2004
    Manufacturer
    HARMAC MED PRODUCTS, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DR PERFORMING A LOOP ELECTROCAUTERY PROCEDURE LEEP WITH A FISCHER CONE BIOPSY EXCISOR #900-152 WHEN SURGEON NOTICED EXCISOR WAS NOT FUNCTIONING. HE WAS GIVEN ANOTHER ONE AND THE PROCEDURE CONTINUED TO COMPLETION. IT WAS NOTICED AFTERWARDS THAT THE WIRE LOOP ON THE FIRST EXCISOR WAS BROKEN AND MISSING. THIS WAS BROUGHT TO THE SURGEON'S ATTENTION AND HE TRIED TO LOCATE THE WIRE BY INSPECTION OF SURGICAL SITE WITH MICROSCOPE AND MANUAL PALPATION. NO WIRE WAS FOUND. PATHOLOGY LOOKED FOR THE WIRE IN THE PATHOLOGY SPECIMEN. THE WIRE WAS NOT FOUND. THE SURGEON BELIEVES THE WIRE WAS SWABBED OUT WHEN THE SITE WAS BEING CLEANED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISCHER CONE BIOPSY EXCISOR HGI HARMAC MED PRODUCTS, INC. 1X FISCHER CONE BIOP D117121

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention