BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI, INC.

    MDR report key: 3249276 · Received July 22, 2013

    Report

    Report Number
    MW5031064
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GYRUS HANDPIECE NOT CAUTERIZING AFTER BEING USED FOR APPROX 1.5 HOURS. SECOND GYRUS HANDPIECE OPENED AND WOULD NOT CAUTERIZE. THIRD HANDPIECE OPENED AND FUNCTIONED. DIFFERENT MACHINES DID NOT MAKE A DIFFERENCE IN THE FUNCTIONING OF THE HANDPIECE. BIOMED CONSULTED TO REVIEW PROBLEM - IDENTIFIED AS NON-GENERATOR RELATED. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340219 GYRUS ACMI, INC. PKS CUTTING FORCEPS 10MM/33CM GEI GYRUS ACMI, INC 921020PK JF514266
    340234 GYRUS ACMI, INC. PKS CUTTING FORCEPS 10MM/33CM GEI GYRUS ACMI, INC JF526414

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR