BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPITCAL ACCESS SYSTEM

    MDR report key: 2093803 · Received May 11, 2011

    Report

    Report Number
    MW5020594
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTION OF CAMERA/SCOPE THROUGH AN APPLIED KII OPTICAL ACCESS SYSTEM 15X100MM TROCAR A CLEAR SEAL PIECE FROM THE TROCAR WAS DISCOVERED LYING ON TOP OF THE STOMACH. THE FALLEN PIECE AND TROCAR WAS IMMEDIATELY REMOVED FROM THE PATIENT AND REPLACED WITH A NEW APPLIED KII TROCAR. AT THE END OF THE CASE WHILE OBSERVING THE REMOVAL OF THE TROCARS, THE SURGEON NOTICED A DARK FOREIGN OBJECT ADHERED TO THE ABDOMINAL WALL. HE REMOVED IT AND IT WAS DETERMINED TO BE A PIECE OF THE INSIDE OF THE FIRST TROCAR. ALL ITEMS PLACED IN BIOHAZARD BAG AND GIVEN TO INVENTORY MANAGER W/EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPITCAL ACCESS SYSTEM GENERAL HOSPITAL PRODUCTS GCJ APPLIED MEDICAL 1136940

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention