BEUDAMED
    FDA Adverse Event Other Summary report: N

    12X100 THR OPT SEP UNIV

    MDR report key: 1335841 · Received March 2, 2009

    Report

    Report Number
    2027111-2009-00016
    Event Type
    Other
    Date Received
    March 2, 2009
    Date of Event
    February 26, 2009
    Report Date
    March 2, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS NOT BEEN RETURNED FOR EVAL. UPON RECEIVING AND EVALUATING THE INCIDENT DEVICE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "THE VALVE OF THE THREADED SEPARATOR WAS TORN. THE DOCTOR TRIED TO PUT GAUZE (30MMX30MM) INTO ABDOMINAL CAVITY THROUGH THE TROCAR BY GRIPPING THE GAUZE WITH THE FORCEPS, AND THE VALVE WAS BROKEN AND THEN THE 2 PIECES OF THE DEBRIS WERE DROPPED. THE DEBRIS WAS RETRIEVED. THE VALVE WAS BROKEN WHEN THE DOCTOR RETRIED AFTER THE GAUZE WAS STUCK HALFWAY. THE DOCTOR RECOGNIZES HE TRIED TOO HARD IN USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100 THR OPT SEP UNIV NONE GCJ APPLIED MEDICAL RESOURCES C0130 1073103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention