BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS LYONS

    MDR report key: 1157803 · Received August 22, 2008

    Report

    Report Number
    1157803
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 22, 2008
    Manufacturer
    GYRUS( ACMI) MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ===== GYRUS PK FORCEPS BROKE INTO TWO PIECES AT THE HINGED ASPECT. DEVICE WAS BEING USED CORRECTLY AND PROPERLY AT THE TIME. FRACTURED HALF WAS RETRIEVED SAFELY AND IS ACCOUNTED FOR.================= MANUFACTURER RESPONSE FOR DISSECTING FORCEPS WITH ATTACHED CORD, PKS LYONS======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS LYONS FORCEPS, BI-POLAR, ESU GEI GYRUS( ACMI) MEDICAL, INC. * 8190038

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR