BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 2550975 · Received April 20, 2012

    Report

    Report Number
    2550975
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 10, 2012
    Manufacturer
    CONMED
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE THE DEVICE STOPPED CLIP APPLICATION AND WOULD NOT START. NO HARM TO THE PATIENT. ANOTHER DEVICE WAS OBTAINED WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ELC CLIP APPLIER GDO CONMED * 1201231

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR