BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE RIP-STOP ENDO POCKET

    MDR report key: 5962802 · Received September 20, 2016

    Report

    Report Number
    5962802
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 4, 2016
    Report Date
    September 9, 2016
    Manufacturer
    JIM HSIEH
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN EXTRACTING THE GALLBLADDER, THE ENDO POCKET BAG BROKE FROM THE BOTTOM OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614100 CAPSURE RIP-STOP ENDO POCKET LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ JIM HSIEH FEPC36100

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NO