BEUDAMED
    FDA Adverse Event Other Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR, 8 MM

    MDR report key: 1728943 · Received June 14, 2010

    Report

    Report Number
    2183680-2010-00029
    Event Type
    Other
    Date Received
    June 14, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 14, 2010
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE OBSERVED SIGNS OF WEAR AND THE DEVICE IS IN NEED OF REPAIR OR REFURBISHMENT. THE DEVICE WAS MANUFACTURED IN SEPTEMBER, 2006. THIS MODEL IS A REUSABLE FALLOPIAN TUBE APPLICATOR WHICH REQUIRES DISASSEMBLY BEFORE STERILIZATION. SINCE THIS MODEL IS REUSABLE IT IS NOT POSSIBLE TO DETERMINE THAT THE NOTED COMPLAINT WAS THE RESULT OF A MANUFACTURING ISSUE, COMPONENT ISSUE, MISUSE OR NORMAL WEAR.

    Description of Event or Problem · 1

    DURING A TUBAL LIGATION PROCEDURE, THE PATIENT'S TUBE WAS CUT WHILE USING THE FALOPE-RING BAND TWO-RING APPLICATOR. COAGULATION WAS USED TO SEAL THE TUBE. ANOTHER APPLICATOR WAS USED ON THE OTHER TUBE WITH NO PATIENT PROBLEMS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND TWO-RING APPLICATOR, 8 MM FALOPE-RING BAND TWO-RING APPLICATOR KNH GYRUS MEDICAL, INC. 000940-501 1669446J

    Patients

    Seq Age Sex Outcome Treatment
    1