BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 188260 · Received September 17, 1998

    Report

    Report Number
    1824347-1998-00011
    Event Type
    Malfunction
    Date Received
    September 17, 1998
    Report Date
    September 16, 1998
    Manufacturer
    IMAGYN SURGICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLIPS MISFIRED ON 1 INSTRUMENT, OPENED ANOTHER INSTRUMENT AND IT MISFIRED. THE METAL PIECE BEHIND THE CLIP BENT ON BOTH INSTRUMENTS. CLIPS WOULD MISFORM AND FELL OUT OF JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ELC ENDOSCOPIC CLIP APPLIER GDO IMAGYN SURGICAL 530 13D03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other