BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMI

    MDR report key: 1211423 · Received October 22, 2008

    Report

    Report Number
    1216677-2008-00034
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 22, 2008
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT INFO IS AVAILABLE. INITIAL REPORTER INQUIRED WHETHER OR NOT THE MORCELLATED PIECES COULD BE SEEN BY X-RAY. COOPERSURGICAL'S CMO INDICATED THE PIECES WOULD NOT BE VISIBLE ON AN X-RAY OR VIA ULTRASOUND DEFINITELY AFTER MORCELLATION. THE DEVICE WILL NOT BE RETURNED. INITIAL REPORTER COULD NOT PROVIDE ANY FURTHER DETAILS REGARDING THE EVENT. REFERENCE COMPLAINT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC AND TUBAL PROCEDURE, THE TIP OF THE UTERINE MANIPULATOR/INJECTOR WAS MISSING WHEN REMOVED FROM THE UTERUS. THE ATTENDING PHYSICIANS MORCELLATED THE TIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention