BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED MEDICAL KII ACCESS SYSTEM

    MDR report key: 2915402 · Received January 10, 2013

    Report

    Report Number
    2915402
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    DURING CASE, 5MM TROCARS HAD TO BE REPLACED TWICE. 1554708 END CAP BROKE OFF DURING PROCEDURE, REPLACED WITH 1522282 WHICH STARTED TO LEAK DURING THE PROCEDURE. THIS WAS REPLACED WITH A 3RD TROCAR. THESE ITEMS WERE REPROCESSED. PROCEDURE HAD TO BE STOPPED EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15670 APPLIED MEDICAL KII ACCESS SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GCJ STERILMED, INC. * *
    15671 APPLIED MEDICAL KII ACCESS SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STERILMED, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR