BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR FORCEPS

    MDR report key: 1070470 · Received July 7, 2008

    Report

    Report Number
    1530493-2008-00001
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 30, 2008
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED AND FOUND AS REPORTED. INSTITUTED CORRECTIVE ACTION. UNIQUE OCCURRENCE, NO FURTHER CORRECTIONS NEEDED.

    Description of Event or Problem · 1

    END-USER REPORTED A HOLE IN THE INSULATION OF THE DEVICE. THE DEVICE CAME IN CONTACT WITH A TABLE AND CAUSED A SMALL BURN TO THE TABLE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FORCEPS GEI OLSEN MEDICAL 42301 009091

    Patients

    Seq Age Sex Outcome Treatment
    1