BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS

    MDR report key: 3151344 · Received June 3, 2013

    Report

    Report Number
    3151344
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    June 1, 2013
    Manufacturer
    GYRUS MEDICAL INC., SUB. OF GYRUS ACMI, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    GYRUS HLO PKS HANDPIECE NOT COAGULATING CONSISTENTLY. OPENED ANOTHER HANDPIECE AND TOOK ORIGINAL OFF FIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COAGULATION/HEMOSTASIS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242587 HALO PKS ELECTROSURGICAL, ACCESSORY, HANDPIECE GEI GYRUS MEDICAL INC., SUB. OF GYRUS ACMI, INC * JF547429

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR