BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 183332 · Received August 14, 1998

    Report

    Report Number
    1824347-1998-00003
    Event Type
    Malfunction
    Date Received
    August 14, 1998
    Report Date
    August 14, 1998
    Manufacturer
    IMAGYN SURGICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING LAP CHOLE AND CUT A VESSEL INADVERTENTLY. WHILE TRYING TO CLIP THE VESSEL THE CLIPS WERE NOT ADVANCING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other