BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESCULAP COHEN UTERINE MANIPULATOR WITH CONE

    MDR report key: 2771696 · Received September 25, 2012

    Report

    Report Number
    MW5027118
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    March 7, 2012
    Report Date
    September 25, 2012
    Manufacturer
    AESCULAP USA
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY THAT WAS CONVERTED TO AN OPEN ABDOMINAL HYSTERECTOMY. DURING THE INITIAL SURGERY THE UTERUS WAS BEING MANIPULATED BY A COHEN UTERINE MANIPULATOR WITH CANNULA CONE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE UTERINE MANIPULATOR WAS REMOVED. AT THE TIME THE UTERINE MANIPULATOR WAS REMOVED IT WAS NOT NOTICED THAT THE CONE WAS NOT RETRIEVED ATTACHED TO THE MANIPULATOR. THE PT FELT THE CONE THE NEXT DAY DURING HER RECOVERY WHEN VOIDING AND THE CONE WAS REMOVED BY THE PT FROM THE VAGINA. THERE WAS NO INJURY TO THE PT. UPON INVESTIGATION WE HAVE FOUND THAT THE CONE COMES OFF VERY EASILY AND WHEN REPORTED HAVE BEEN TOLD IT IS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESCULAP COHEN UTERINE MANIPULATOR WITH CONE UTERINE MANIPULATOR LKF AESCULAP USA ER876
    2 AESCULAP COHEN UTERINE MANIPULATOR WITH CONE UTERINE MANIPULATOR LKF AESCULAP USA ZU 876

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR