BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX TL

    MDR report key: 1221303 · Received October 26, 2008

    Report

    Report Number
    1221303
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 26, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING STALER TO CLOSE SKIN AND THE STAPLES WERE NOT CLOSING PROPERLY, THE STAPLE ENDS WERE POINTING OUTWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX TL STAPLER, SURGICAL, SKIN GDT CONMED CORPORATION * 0805162

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR