BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR, 6 MM

    MDR report key: 1586755 · Received January 13, 2010

    Report

    Report Number
    2183680-2010-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 7, 2009
    Report Date
    January 13, 2009
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE DEVICE FOUND DAMAGE TO THE ID TUBE. THE TIP WAS FILED/SHORTENED AND SHARP. THE OD TUBE WAS ALSO NICKED. THE APPLICATOR WAS MISSING A LOCK SCREW AND THE TONGS WERE MISALIGNED. THIS IS A REUSABLE DEVICE. THIS TYPE OF DAMAGE HAS BEEN ATTRIBUTED TO NORMAL WEAR WHICH CAN BE CAUSED BY DISASSEMBLY AND CLEANING AT THE HOSP'S CENTRAL PROCESSING FACILITIES.

    Description of Event or Problem · 1

    DURING A TUBAL LIGATION PROCEDURE, THE SURGEON REPORTED THAT THE FALOPE-RING BAND APPLICATOR WAS CUTTING THE TUBES. THE SURGEON WAS ABLE TO FIRE OFF THE RING BEFORE ANY DANGEROUS BLEEDING TO THE PT OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND TWO-RING APPLICATOR, 6 MM FALOPE-RING BAND TWO-RING APPLICATOR KNH GYRUS MEDICAL INC. 000941-501 75741OL

    Patients

    Seq Age Sex Outcome Treatment
    1