BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII

    MDR report key: 3861396 · Received May 23, 2014

    Report

    Report Number
    3861396
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 23, 2014
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BLACK SEAL AND WHITE "CAGE" BROKE FREE OF THE TROCAR AND WAS FOUND IN THE PATIENT'S ABDOMEN. THE PIECES WERE REMOVED WITHOUT INJURY TO THE PATIENT OR PROVIDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307770 KII TROCAR, LAPAROSCOPIC GCJ APPLIED MEDICAL RESOURCES CORP. * 1213165

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NO OTHER THERAPIES