BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIL FIOS FIRST ENTRY

    MDR report key: 5384796 · Received January 20, 2016

    Report

    Report Number
    MW5059558
    Event Type
    Malfunction
    Date Received
    January 20, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 7, 2016
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO INSERT TROCAR #1 FOR LAPAROSCOPIC SURGERY AND THE DEVICE BROKE, THEN ATTEMPTED TO INSERT TROCAR #2 AND THE DEVICE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40370 KIL FIOS FIRST ENTRY TROCAR GCJ APPLIED MEDICAL 1198528
    40371 KIL FIOS FIRST ENTRY TROCAR GCJ APPLIED MEDICAL 1248764

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR