BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FALOPE-RING BAND APPLICATOR KIT

    MDR report key: 3212855 · Received April 2, 2013

    Report

    Report Number
    2183680-2013-00018
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    August 24, 2012
    Report Date
    March 6, 2013
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS DISPOSED OF BY THE FACILITY, NO DEVICE IS AVAILABLE FOR INVESTIGATION. THE COMPLAINT WILL BE LOGGED FOR TRENDING PURPOSES. A REVIEW OF THE LOT HISTORY RECORDS DOES NOT INDICATE ANY DISCREPANCIES IN THE MANUFACTURE OF THE LOT. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    GYRUS ACMI, INC. WAS NOTIFIED BY A UF MEDWATCH REPORT THAT DURING A LAPAROSCOPIC TUBAL LIGATION, AS THE SURGEON WAS INSERTING THE FALOPE-RING APPLICATOR, A PIECE OF THE WASHER FROM THE DISPOSABLE SUPRAPUBIC TROCAR BROKE OFF AND WENT INTO THE ABDOMINAL CAVITY. THE PIECE WAS RETRIEVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135619 DISPOSABLE FALOPE-RING BAND APPLICATOR KIT DISPOSABLE FALOPE-RING BAND APPLICATOR KNH GYRUS MEDICAL, INC. 005280-901 430557CE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN