BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMI

    MDR report key: 509280 · Received January 29, 2004

    Report

    Report Number
    1216677-2004-00001
    Event Type
    Other
    Date Received
    January 29, 2004
    Report Date
    January 23, 2004
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPRASCOPIC TUBAL LIGATION, THE DEVICE WAS INSERTED INTO THE PT'S CERVIX AND THE TIP BROKE OFF. THE BROKEN PIECE WAS REMOVED MANUALLY (FINGERS OR FORCEPS). THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMI UTERINE MANIPULATOR/INJECTOR LKF COOPERSURGICAL, INC. 6001 24210

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention