BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CARE

    MDR report key: 1001238 · Received February 22, 2008

    Report

    Report Number
    1320894-2008-00021
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 22, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED FOR EVAL. NO LOT CODE WAS PROVIDED FOR THE DEVICE. WITHOUT THE DEVICE AND/OR LOT CODE WE ARE UNABLE TO INVESTIGATE THE REPORTED COMPLAINT. WE ARE CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A PROCEDURE, THE HANDLE ON THE V-CARE SEPARATED FROM THE DEVICE, IN THAT IT LOST ITS STABILITY AND WAS SPINNING FREELY".

    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