BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMI

    MDR report key: 494027 · Received November 4, 2003

    Report

    Report Number
    1216677-2003-00018
    Event Type
    Other
    Date Received
    November 4, 2003
    Date of Event
    October 24, 2003
    Report Date
    November 3, 2003
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED MANUALLY (FINGERS OR FORCEPS). THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMI UTERINE INJECTOR LKF COOPERSURGICAL, INC. 6001 24212

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention