BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CARE

    MDR report key: 1002767 · Received February 26, 2008

    Report

    Report Number
    1320894-2008-00023
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND IS IN THE PROCESS OF BEING EVALUATED. WHEN I RECEIVE THE INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A PROCEDURE, THE WHITE HANDLE STARTED ROTATING ON THE SHAFT. REPLACED THE DEVICE WITH ANOTHER AND FINISHED THE PROCEDURE." NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CARE UTERINE MANIPULATOR LKF CONMED CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK