BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR ELEVATOR

    MDR report key: 1791531 · Received July 21, 2010

    Report

    Report Number
    1320894-2010-00100
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    CONMED CORPROATION
    Product Code
    LKF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FDA REPORTABLE DUE TO SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2008-00147. THE DEVICE IS NOT BEING RETURNED TO CONMED FOR IT HAS BEEN DISCARDED BY THE END-USER. LOT HISTORY WAS NOT PERFORMED AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT AVAILABLE. HOWEVER, ALL VCARE DEVICE PASS IN-PROCESS AND FINAL INSPECTION FUNCTIONAL TESTING PRIOR TO RELEASE. THEREFORE, THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED OR CONFIRMED ANY MANUFACTURING DEFECTS WITH THIS DEVICE. THE CAUSE OF THIS COMPLAINT IS UNDETERMINED. THE POSSIBLE CAUSE OF THIS COMPLAINT IS APPLICATION OF FORCE WHICH EXCEEDED THE CERVICAL CONE PULL OFF STRENGTH CAPABILITY OF THE DEVICE. THIS WOULD ALLOW THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE, DETACHING THE UTERINE BALLOON. THE ROOT CAUSE OF THE EXCESSIVE FORCE MAY HAVE BEEN ATTEMPTING TO REMOVE A LARGE UTERUS THROUGH THE VAGINAL CANAL. USER TECHNIQUE MAY HAVE BEEN A CONTRIBUTING FACTOR. THE DIRECTIONS FOR USE STATES, "MORCELLATION OR OTHER MEANS SHOULD BE USED TO REDUCE THE SIZE OF A UTERUS DEEMED TOO LARGE BEFORE ATTEMPTING TO REMOVE THROUGH THE VAGINAL CANAL." CONMED CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "UPON REMOVAL OF THE SPECIMEN AND VCARE, THE BALLOON AND COLPOTOMY CUP BECAME SEPARATED FROM THE VCARE." IT WAS ALSO REPORTED THAT THERE WAS NO INJURY INCURRED BY THE PATIENT, AND THE BALLOON AND CUP WERE BOTH RETRIEVED FROM THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK