BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS/GYRUS ACMI

    MDR report key: 2032336 · Received March 10, 2011

    Report

    Report Number
    2032336
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    GYRUS ACMI
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE ELECTRODE FOR NO LONGER THAN ONE MINUTE, THE ELECTRODE BROKE. THIS HAPPENED TWICE. FOR THE THIRD TRY THE SAME TYPE OF ELECTRODE WAS USED FROM A DIFFERENT BOX AND DIFFERENT LOT NUMBER AND WORKED. THE MANUFACTURER RESPONSE FOR HF RESECTION ELECTRODE, LOOP, OLYMPUS/GYRUS ACMI IS: RETURN IT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS/GYRUS ACMI HF RESECTION ELECTRODE, LOOP FAS GYRUS ACMI WA22306D 10277P00L001

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN.