BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V CARE STANDARD VAGINAL MANIPULATOR

    MDR report key: 2182328 · Received July 22, 2011

    Report

    Report Number
    MW5021515
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A SUPRACERVICAL HYSTERECTOMY USING THE DAVINCI SURGICAL ROBOT. PART OF SURGICAL SET-UP INCLUDED THE CONMED VCARE UTERINE MANIPULATOR. AT THE END OF THE CASE, MD DID NOT CHECK SURGICAL FIELD. PT CAME INTO MD'S OFFICE IN (B)(6), AND WHEN DOING A VAGINAL EXAM, MD FOUND GREEN CUP FROM THE END OF THE VAGINAL MANIPULATOR. IT ALSO APPEARS THAT PART OF THE DEFLATED BALLOON IS STUCK TO THE INTERIOR OF THE CUP. CUP BROUGHT TO HOSPITAL RISK MGMT OFFICE BY MD OFFICE STAFF. PACKAGING WITH LOT # AND SERIAL NUMBER AND DEVICE WERE DISCARDED IMMEDIATELY POST-IT. IT WAS NOT NOTICED UNTIL PT'S FOLLOW-UP VISIT THAT ANYTHING WAS WRONG WITH PROCEDURE OR MANIPULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V CARE STANDARD VAGINAL MANIPULATOR VAGINAL MANIPULATOR LKF CONMED CORPORATION REF # 60-6085-100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other