BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSCOPIC CLIP APPLIER

    MDR report key: 295298 · Received September 7, 2000

    Report

    Report Number
    1824347-2000-00026
    Event Type
    Other
    Date Received
    September 7, 2000
    Report Date
    August 11, 2000
    Manufacturer
    IMAGYN SURGICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PARTIAL CLIP FORMATION, HEMOSTASIS WAS NOT ACHIEVED. SURGEON WENT IN WITH ANOTHER INSTRUMENT TO STOP THE BLEEDING. PT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO IMAGYN SURGICAL 530 16F00

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other