BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS

    MDR report key: 2992222 · Received February 28, 2013

    Report

    Report Number
    2992222
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    HIN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT CUTTING FORCEPS WERE DULL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TOTAL LAPAROSCOPIC HYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87274 HALO PKS ELECTROSURGICAL, CUTTING & COAGULATION HIN GYRUS ACMI, INC 5MM/33CM JF514277

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR