BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR, 6 MM

    MDR report key: 1586991 · Received January 15, 2010

    Report

    Report Number
    2183680-2010-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 17, 2009
    Report Date
    January 15, 2010
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    P980076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS OBSERVED THAT THE TONGS AND HANDLE ON THE FALOPE-RING APPLICATOR WERE MISALIGNED. ALSO, THE ID TUBE WAS FOUND TO BE NICKED. IT APPEARS THE DEVICE COULD HAVE BEEN MISHANDLED DURING DISASSEMBLY WHICH IS REQUIRED FOR THE CLEANING AND STERILIZING PROCESS. THE CAUSE OF THE TUBE TEARING DURING THE BAND APPLICATION CANNOT BE DETERMINED DUE TO NOT KNOWING HOW MANY TIMES IT HAS BEEN USED AND PROCESSED.

    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 BAND THE TUBE BEFORE THERE WAS ANY HARM TO THE PATIENT.

    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. 000940-501 82317BB

    Patients

    Seq Age Sex Outcome Treatment
    1