BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMI

    MDR report key: 540579 · Received March 24, 2004

    Report

    Report Number
    1216677-2004-00003
    Event Type
    Other
    Date Received
    March 24, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 23, 2004
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE END SNAPPED OFF THE MANIPULATOR. THE BROKEN PIECE WAS REMOVED MANUALLY WITH RING FORCEPS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMI UTERINE MANIPULATOR/INJECTOR LKF COOPERSURGICAL, INC. 6001 26400

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention