BEUDAMED
    FDA Adverse Event Other Summary report: N

    C0Q04, KII 5X100 THR OPT SEP SYS

    MDR report key: 1141354 · Received August 28, 2008

    Report

    Report Number
    2027111-2008-00037
    Event Type
    Other
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 28, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RETURNED FROM HOSPITAL AND IS CURRENTLY UNDER INVESTIGATION. FINAL REPORT WILL FOLLOW UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    "DR USED APPLIED'S 5MMX100MM OPTICAL SEPARATOR. DURING HIS FIRST STICK, HE ENCOUNTERED RESISTANCE USING HIS SMITH & NEPHEW 5MM 0DEGREE HIGH DEFINITION SCOPES. AFTER WHICH HE USED A DIFFERENT TROCAR AND GAINED ENTRY. HOWEVER; WHEN REMOVING THE SCOPE, THE GREEN CAP FOR THE OPTICAL ENTRY CAME OFF. THEN TO COMPOUND THE ISSUE, WHEN INSERTING THE SCOPE BACK INTO THE PATIENT AFTER INSUFFLATION, PLASTIC SHARDS WERE TRANSFERRED FROM THE SHAFT OR LENS OF THE SCOPE INTO THE PATIENT'S ABDOMEN. THIS RESULTED IN LONGER OR TIME, BUT ALL SHARDS WERE REMOVED FROM WITHIN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C0Q04, KII 5X100 THR OPT SEP SYS NONE GCJ APPLIED MEDICAL RESOURCES C0Q04 1038825

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization