BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE FALOPE-RING BAND APPLICATOR KIT

    MDR report key: 1666426 · Received April 21, 2010

    Report

    Report Number
    2183680-2010-00015
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    March 13, 2010
    Report Date
    April 21, 2010
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN 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 PROCEDURE WHILE USING THE FALOPE RING BAND APPLICATOR, THE FALLOPIAN TUBE WAS CUT WHEN THE JAWS WERE RETRACTED BACK INTO THE INSTRUMENT. THERE WAS NO PATIENT HARM OR PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FALOPE-RING BAND APPLICATOR KIT DISPOSABLE FALOPE-RING BAND APPLICATOR KNH GYRUS MEDICAL, INC. 005280-901 151299AC

    Patients

    Seq Age Sex Outcome Treatment
    1