BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE FALOPE-RING BAND APPLICATOR

    MDR report key: 2093312 · Received April 14, 2011

    Report

    Report Number
    2183680-2011-00008
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PROCEDURE USING THE DISPOSABLE FALOPE-RING BAND APPLICATOR WHILE DEPLOYING THE BANDS APPLICATOR, THE DEVICE STARTED TO CUT THE FALLOPIAN TUBE. THE SURGEON STOPPED AND TRIED ANOTHER LIKE DEVICE. SECOND DEVICE DID THE SAME THING. (SEE MEDWATCH MFG #2183680-2011-00007 FOR 1ST DEVICE) THE SURGEON WAS NOT WORRIED ABOUT THE TUBE AS THAT PART WOULD DIE OFF AFTER THE BAND WAS APPLIED. A 3RD LIKE DEVICE WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. NO LONGER HOSPITALIZATION STAY WAS REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FALOPE-RING BAND APPLICATOR BAND APPLICATOR KNH GYRUS MEDICAL INC. 006889-901 250724KC

    Patients

    Seq Age Sex Outcome Treatment
    1