BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR

    MDR report key: 2619798 · Received June 7, 2012

    Report

    Report Number
    2183680-2012-00031
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 11, 2012
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TUBAL WITH FALOPE RINGS, THE INSTRUMENT DID NOT ENGAGE AND FALLOPIAN TUBE WAS TRANSECTED. THE SURGEON SWITCHED TO TUBALIGATION USING ANOTHER DEVICE. NO OTHER PT ISSUES.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK