BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FALOPE-RING BAND APPLICATION KIT

    MDR report key: 3012555 · Received March 15, 2013

    Report

    Report Number
    2183680-2013-00012
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    K870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE BEING USED CUT THE FALOPIAN TUBE. ANOTHER DEVICE WAS OPENED WHICH CUT THE TUBE ON THE OTHER SIDE. BOTH TUBES HAD TO BE CAUTERIZED. MFR NUMBER: (2183680-2013-00013 FOR SECOND DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110847 DISPOSABLE FALOPE-RING BAND APPLICATION KIT FALOPE-RING BAND APPLICATION KIT KNH GYRUS MEDICAL, INC. 006889-901 MK483726

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other