BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12X100MM REUSABLE DURAGOLD RADIOLUCENT CANNULA

    MDR report key: 1915465 · Received November 4, 2010

    Report

    Report Number
    2027111-2010-00101
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    May 12, 2010
    Report Date
    November 4, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ENGINEER EVAL, A F/U REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION

    Description of Event or Problem · 1

    "WHEN DISCONNECTING THE INSUFFLATION TAP FROM THE SUBUMBILICAL TROCAR, THERE WAS A FRACTURE OF SUBUMBILICAL TROCAR EXTERNAL TO THE ABDOMINAL CAVITY SEVERAL CENTIMETERS ABOVE THE SKIN. SEVERAL PIECES OF THE CANNULA FELL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED AND X-RAYS WERE PERFORMED TO ENSURE NO FOREIGN OBJECTS REMAINED IN PATIENT. (B)(6) HOSPITAL IMMEDIATELY FILED A USER REPORT WITH THE FDA REGARDING THIS INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM REUSABLE DURAGOLD RADIOLUCENT CANNULA REUSABLE CANNULA GCJ APPLIED MEDICAL RESOURCES C0E02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1