BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 1062165 · Received June 13, 2008

    Report

    Report Number
    1320894-2008-00080
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN I RECEIVE THE INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "VCARE STANDARD UTERINE MANIPULATOR HANDLE BROKE DURING SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION NA 0802111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK