BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW

    MDR report key: 1013007 · Received March 5, 2008

    Report

    Report Number
    1013007
    Event Type
    Malfunction
    Date Received
    March 5, 2008
    Date of Event
    January 14, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND A CLEARVIEW UTERINE MANIPULATOR WAS USED. THE MANIPULATOR WAS PLACED INSIDE THE UTERUS. THE MANIPULATOR HAS A SPACER THAT IS TO BE PLACED ON THE MANIPULATOR IF THE UTERUS SOUNDS TO LESS THAN 10 CM. THE SPACER WAS ON THE MANIPULATOR DURING THIS SURGICAL PROCEDURE. APPARENTLY THE SPACER BECAME DETACHED DURING THE PROCEDURE BUT THE SURGEON WAS UNAWARE OF THE DETACHMENT. THE MANIPULATOR AND THE SPACER ARE BOTH WHITE IN COLOR SO WHEN THE MANIPULATOR WAS REMOVED IT WAS NOT APPARENT THAT THE SPACER WAS NO LONGER ATTACHED. THE PATIENT FELT PAIN AND CALLED HER PHYSICIAN. THE PHYSICIAN FOUND THE SPACER AND REMOVED IT A MONTH LATER IN HER OFFICE. THE PHYSICIAN COMMENTED THAT THE SPACER WAS ABLE TO MIGRATE TO WHERE THE PATIENT COULD FEEL IT, THUS PROMPTING THE PATIENT TO CALL THE DOCTOR. PRIOR TO THE PROCEDURE, THE PHYSICIAN WAS UNAWARE THAT THE SPACER COULD COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW UTERINE MANIPULATOR LKF CLINICAL INNOVATIONS, INC. * 070504

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR