BEUDAMED
    FDA Adverse Event Summary report: N

    12 X 60 MM KII OPTICAL ACCESS SYSTEM THREADED 6/BOX

    MDR report key: 2992711 · Received March 1, 2013

    Report

    Report Number
    2027111-2013-00067
    Date Received
    March 1, 2013
    Date of Event
    December 10, 2012
    Report Date
    March 1, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL BUT THE LOT NUMBER IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, 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

    MYOMECTOMY - "IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON FOUND A PIECE OF RUBBER WHICH WAS LATER FOUND TO BE A PIECE OF THE SEPTUM DEAL TORN OFF. THE PIECE WAS RETRIEVED AND THERE WAS A MINOR AIR LEAKAGE BUT THE PROCEDURE CONTINUED NORMALLY WITHOUT ANY OTHER INCIDENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89417 12 X 60 MM KII OPTICAL ACCESS SYSTEM THREADED 6/BOX NONE GCJ APPLIED MEDICAL C0R83 11693314

    Patients

    Seq Age Sex Outcome Treatment
    1