BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 1998027 · Received February 9, 2011

    Report

    Report Number
    1998027
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 9, 2011
    Manufacturer
    CONMED ENDOSURGERY
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DURING OPERATION, THE CONMED REFLEX ELC TITANIUM CLIP APPLIER WAS BEING USED WHEN THE SURGEON NOTICED IT BEGAN TO MISFIRE WHEN ACTIVATED. NO PATIENT HARM AND THE UNIT WAS TAKEN OUT OF SERVICE AND SAVED FOR EVALUATION.====================== MANUFACTURER RESPONSE FOR TITANIUM CLIP APPLIER, REFLEX ELC======================NONE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ELC CLIP APPLIER GDO CONMED ENDOSURGERY REF 530 1008161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES