BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FALOPE RING BAND APPLICATOR KIT

    MDR report key: 2630965 · Received June 21, 2012

    Report

    Report Number
    2183680-2012-00032
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DURING A TUBAL LIGATION, THE INSTRUMENT GRASPERS GAVE WAY WHEN THE FALLOPIAN TUBE WAS BEING DRAWN INTO THE INSTRUMENT WHICH THEN CAUSED THE FALLOPIAN TUBE TO BE TRANSECTED. THE SURGEON CAUTERIZED THE TUBE AND USED ANOTHER INSTRUMENT FROM THE SAME BOX WITH THE SAME RESULT. USED A COMPETITOR'S PRODUCT TO FINISH THE CASE. NO OTHER ISSUES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FALOPE RING BAND APPLICATOR KIT FALOPE RING BAND APPLICATOR KIT KNH GYRUS MEDICAL INC. 006889-901 419414BE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other