BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSU 2 EXTENDER 28CM

    MDR report key: 5764927 · Received July 1, 2016

    Report

    Report Number
    1717344-2016-00579
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    April 26, 2016
    Report Date
    June 6, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    PMA / PMN Number
    K926481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO REPORT MW5062168, THE TOP SMALL BLACK PART OF THE ARGON PIECE CAME OFF AND WAS NOTICED AFTER USE. NO KNOWN HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420078 GSU 2 EXTENDER 28CM ES ACCESSORY GEI COVIDIEN LP E253028 51090054X

    Patients

    Seq Age Sex Outcome Treatment
    1