BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR

    MDR report key: 2003623 · Received February 23, 2011

    Report

    Report Number
    2183680-2011-00005
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 23, 2011
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH BENT TONGS AND A MISALIGNED THUMB HANDLE TUBE ASSEMBLY. IT IS ALSO NOTED THAT THE DEVICE WAS RETURNED WITH A NON-GYRUS ACMI TYPE OF LOCKING SCREW. THIS DEVICE WAS MANUFACTURED IN JULY 2006 AT THE (B)(4) PLANT WHICH IS NO LONGER IN OPERATION. THE TONGS WERE FOUND TO BE OUT OF SPECIFICATION; HOWEVER, DUE TO THE NATURE OF THIS DEVICE BEING A RE-USABLE ITEM, IT IS NOT POSSIBLE TO DETERMINE WITH CONFIDENCE THAT THE NOTED DAMAGED TONGS WERE A RESULT OF A MANUFACTURING OR DESIGN ISSUE AFTER 5 YEARS IN THE FIELD. THE NON-GYRUS ACMI LOCKING SCREW INDICATES THAT THE DEVICE HAS BEEN REPAIRED BY A 3RD PARTY AT SOME POINT IN TIME.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE FALOPE RING BAND WAS USED TO GRASP THE PT'S LEFT TUBE, WHEN ATTEMPTING TO APPLY THE RING BAND, THE TUBE WAS TORN. A SECOND DEVICE WAS USED TO APPLY THE RIGHT SIDE RING BAND, THIS TUBE ENDED UP WITH A SLIGHT TEAR. THE LEFT TUBE WAS OOZING BLOOD. IN ORDER TO BE SURE THE BLEEDING STOPPED, THE LEFT TUBE WAS REMOVED. NO FURTHER COMPLICATIONS FOR THE PT. (SEE MFR REPORT # 2183680-2011-00006 FOR OTHER DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND TWO-RING APPLICATOR FALOPE-RING BAND TWO-RING APPLICATOR KNH GYRUS MEDICAL, INC. 000940-501 1614586C

    Patients

    Seq Age Sex Outcome Treatment
    1