BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLINE 10MM REUSABLE ENDOCLIP

    MDR report key: 1571435 · Received December 31, 2009

    Report

    Report Number
    MW5014231
    Event Type
    Injury
    Date Received
    December 31, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 31, 2009
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOCLIP APPLIER USED TO CLIP VASCULAR/DUCT OF GALLBLADDER. ENDOCLIP APPLIED AND BOWED IN MIDDLE AND WAS TIGHT AT THE TIP. CLIP REMOVED AND ANOTHER CLIP APPLIED. PATIENT DEVELOPED BILE LEAK REQUIRING ERCP WITH STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLINE 10MM REUSABLE ENDOCLIP NONE FZP MICROLINE SURGICAL
    2 MICROLINE PENTAX NONE FZP MICROLINE SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Disability