BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE FALOPE-RING BAND APPLICATION KIT

    MDR report key: 2110903 · Received March 29, 2011

    Report

    Report Number
    2183680-2011-00002
    Event Type
    Other
    Date Received
    March 29, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    K870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL 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 (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC BILATERAL TUBAL LIGATION, THE SURGEON INSERTED THE FALOPE RING APPLICATOR AND THE TIPS WERE USED TO GRASP AROUND THE LEFT FALLOPIAN TUBE. AS THE GRASPERS WERE CLOSED AND BROUGHT UP INTO THE FALOPE RING APPLICATOR, THE TUBE WAS CUT IN HALF FROM THE DEVICE. THIS PROCEDURE WAS REPEATED AND AGAIN THE TUBE WAS CUT BY THE DEVICE. THE SURGEON DETERMINED THE APPLICATOR WAS DEFECTIVE AND PROCEEDED TO USE KLEPPINGER CAUTERY TO LIGATE THE LEFT FALLOPIAN TUBE. THE SURGEON APPLIED TO THE FALOPE RING APPLICATOR TO THE RIGHT FALLOPIAN TUBE. THE SURGEON GRASPED THE FALLOPIAN TUBE AND BROUGHT IT UP INTO THE CLAMP, HOWEVER, NOT VERY BIG BUCKLE OF TUBE WAS NOTED AND THE RING WAS NOT ABLE TO BE USED. THE SURGEON PROCEEDED WITH THE KLEPPINGER CAUTERY TO LIGATE THE RIGHT FALLOPIAN TUBE. NO LONGER STAY FOR PT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FALOPE-RING BAND APPLICATION KIT FALOPE RING APPLICATOR KNH GYRUS MEDICAL, INC. 006889-901 246433KC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR