BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR ELEVATOR

    MDR report key: 1851026 · Received September 27, 2010

    Report

    Report Number
    1320894-2010-00116
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 24, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FDA REPORTABLE DUE TO SENTINEL EVENT REPORTED ON MEDWATCH'S 1320894-2008-00147. THE DEVICE IS NOT BEING RETURNED TO CONMED. HOWEVER, A SUPPLEMENTAL REPORT WILL BE FILED AFTER THE QUALITY ENGINEERING INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY, "SPECIMEN WAS BEING EXTRACTED THROUGH VAGINA, V-CARE WAS ATTACHED TO FUNDUS, ON REMOVAL END CAP AND BALLOON CAME OFF AND REMAINED IN THE PT. CUP AND BALLOON REMOVED FROM PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE VAGINAL-CERVICAL RETRACTOR ELEVATOR VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION NA 0910122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK