BEUDAMED
    FDA Adverse Event Summary report: N

    12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR

    MDR report key: 3032809 · Received March 25, 2013

    Report

    Report Number
    2027111-2013-00093
    Date Received
    March 25, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 22, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP ANTERIOR RESECTION - "((B)(6) WAS THE SURGEON) (INFO FROM (B)(6)). TROCAR WAS INSERTED W/O ISSUE. JUST BEFORE CONVERTING FROM LAP TO OPEN, SURGEON NOTICED BLACK MATERIAL WITHIN THE PT. THIS BLACK MATERIAL WAS REMOVED. TROCAR SEAL WAS EXAMINED AND (B)(6) NOTICED IT WAS FROM THE INNER SEAL WITHIN THE SEAL HOUSING. AN INTERNAL (B)(4) REPORT WAS COMPLETED BY SURGEON, BUT THE SISTERS DID NOT HAVE ACCESS TO IT." PT STATUS: PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121614 12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR NONE GCJ APPLIED MEDICAL CTB73 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1