BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYONS DISSECTING

    MDR report key: 867727 · Received June 5, 2007

    Report

    Report Number
    867727
    Event Type
    Malfunction
    Date Received
    June 5, 2007
    Date of Event
    April 16, 2007
    Report Date
    June 5, 2007
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE DISSECTING LYONS FORCEPS (MODEL NUMBER: 3700PK) MANUFACTURED BY GYRUS MEDICAL, INC. FAILED. THERE IS EVIDENCE THAT THE PLASTIC NEAR THE END OF THE DEVICE (THE BLACK SHAFT SHEATH) MELTED. THIS IS THE SECOND TIME THE SAME ISSUE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYONS DISSECTING FORCEPS, ESU GEI GYRUS MEDICAL, INC. 3700PK 7043046
    2 LYONS DISSECTING FORCEPS, ESU GEI GYRUS MEDICAL, INC. 3700PK 7043046

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR
    2 40 YR