BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMAN UTERINE MANIPULATOR

    MDR report key: 1944048 · Received December 27, 2010

    Report

    Report Number
    MW5018736
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 27, 2010
    Manufacturer
    COOPER SURGICAL
    Product Code
    HCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A LAPAROSCOPIC PROCEDURE WHERE SURGEON WAS USING A HERMAN UTERINE MANIPULATOR. THE TIP OF THE MANIPULATOR CAME OFF WITHOUT THE SURGEON'S KNOWLEDGE. THE TIP DOES NOT FIT SECURELY ONTO THE HANDLE. THERE WAS NO UNTOWARD OUTCOME FOR THE PT, HOWEVER, AFTER EXAMINING THE OTHER HERMAN UTERINE MANIPULATOR IN STOCK THAT TIP ALSO DID NOT FIT SECURELY AND ALLOWED FOR THE TIP TO EASILY COME OFF THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMAN UTERINE MANIPULATOR UTERINE MANIPULATOR HCY COOPER SURGICAL 22635

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR