BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    MDR report key: 2446423 · Received February 10, 2012

    Report

    Report Number
    1320894-2012-00007
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    December 16, 2011
    Report Date
    April 4, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2011-00062, AND, MEDWATCH 1320894-2011-00091, FOR CONMED'S VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR. THE MAUDE REPORT RECEIVED BY CONMED ON 30 JANUARY 2012 IS CONMED'S FIRST AWARENESS OF THIS EVENT. THE MAUDE REPORT DOES NOT LIST A CURRENT CATALOG NUMBER FOR A CONMED DEVICE; THEREFORE, THE CATALOG NUMBER IN THIS MEDWATCH IS REPORTED AS UNKNOWN. ALSO, CONMED CANNOT ASSUME THAT THE DEVICE UTILIZED IN THE EVENT WAS FROM ONE OF THE LISTED LOT NUMBERS REPORTED AS BEING "IN HOUSE" BY THE INITIAL REPORTER; THEREFORE, THE LOT NUMBER IN THIS MEDWATCH IS REPORTED AS UNKNOWN. CONMED IS ATTEMPTING TO RETRIEVE ADDITIONAL INFORMATION FROM THE REPORTER REGARDING THIS REPORTED ISSUE. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED EVENT A SUPPLEMENTAL REPORT WILL BE FILED. OTHER TEXT : DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION, VCARE, IS A DISPOSABLE, SINGLE-USE DEVICE FOR MANIPULATION OF THE UTERUS AND CERVIX IN SURGICAL AND DIAGNOSTIC PROCEDURES. THE DEVICE CONSISTS OF A MANIPULATOR TUBE HAVING AN INFLATABLE BALLOON AT ITS PROXIMAL END AND AN ANATOMICALLY CONFIGURED CANNULA / HANDLE FOR MAINTAINING PROPER ATTITUDE OF THE UTERUS AT THE DISTAL END. THE VCARE INCORPORATES A SYSTEM OF CUP-LIKE ELEVATORS TO PROVIDE MANIPULATION OF THE UTERUS, AND RETRACTION AND ELEVATION OF THE CERVIX. THE CONMED VCARE IS INDICATED FOR MANIPULATION OF THE UTERUS AND INJECTION OF FLUIDS OR GASES DURING LAPAROSCOPIC PROCEDURES SUCH AS LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH), TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), MINILAP, LAPAROSCOPIC TUBAL OCCLUSION, OR DIAGNOSTIC LAPAROSCOPY AND ALSO MAINTAINS PNEUMOPERITONEUM BY SEALING THE VAGINA ONCE A COLPOTOMY IS PERFORMED. DHR / LHR, DEVICE HISTORY RECORD / LOT HISTORY RECORD, REVIEW WAS NOT COMPLETED BECAUSE THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION OF THE DEVICE COULD NOT BE ASSESSED (I.E., ANY DEVICE DAMAGE, MALFUNCTION OR DEFECTS), AND, CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT COULD NOT BE ACCOMPLISHED. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT UTILIZING THE INITIAL REPORTER INFORMATION FROM THE MAUDE REPORT; HOWEVER, TO DATE THERE HAVE BEEN NO RESPONSES FROM THE END-USER FACILITY. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS APPLICATION OF FORCE WHICH EXCEEDED THE CERVICAL CONE / INTRA-UTERINE BALLOON PULL OFF STRENGTH CAPABILITY OF THE DEVICE. THIS WOULD ALLOW THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE, DETACHING THE INTRA-UTERINE BALLOON FROM THE DEVICE. USER TECHNIQUE MAY HAVE BEEN A CONTRIBUTING FACTOR. RETRACTING THE VAGINAL CONE IN THE VAGINAL CAVITY PRIOR TO DEVICE REMOVAL MAY ALLOW FOR AN EASIER REMOVAL OF THE DEVICE. A SMALL VAGINAL CAVITY OR THE PARTICULAR SHAPE OF THE VAGINAL CANAL MAY ALSO INCREASE REMOVAL FORCE ON THE DEVICE IF THE VAGINAL CONE IS NOT REMOVED PROPERLY PER DFU INSTRUCTIONS. THE RISK ASSOCIATED WITH THIS COMPLAINT IS MITIGATED IN THE VCARE DFU WHICH STATES, "UNLOCK THE LOCKING MECHANISM BY TURNING THE THUMB-SCREW COUNTER-CLOCKWISE (ANTI-CLOCKWISE). SWIPE FINGER AROUND THE VAGINAL CONE TO RELEASE CONE FROM THE VAGINAL TISSUE. RETRACT THE BLUE TUBE BACK TO THE MOLDING HAND ASSEMBLY. CAREFULLY REMOVE THE DEVICE FROM THE VAGINA. DO NOT USE EXCESSIVE FORCE TO AVOID TRAUMATIZING THE VAGINAL CANAL. BEFORE DISPOSING OF VCARE, VISUALLY INSPECT THE DEVICE TO CHECK IT IS INTACT AND ALL FORWARD COMPONENTS (INTRAUTERINE BALLOON, CERVICAL AND VAGINAL CONES, LOCKING ASSEMBLY AND THUMBSCREW) HAVE BEEN REMOVED FROM THE PATIENT." NO ROOT CAUSES CAN BE CONCLUSIVELY CONFIRMED WITHOUT EXAMINATION OF THE ACTUAL DEVICE. NO CONCLUSIVE MANUFACTURING RELATED CAUSES WERE DETERMINED DURING THE INVESTIGATION; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. CONMED CORPORATION IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE NOT AVAILABLE FROM END-USER.

    Description of Event or Problem · 1

    THIS WAS REPORTED TO CONMED BY THE FDA MAILING OF MAUDE EVENT REPORT (FOI) REPORT NUMBER (B)(4) RECEIVED OF CONMED ON 30 JANUARY 2012. THE REPORT STATES THAT, " WHEN REMOVING CONMED MANIPULATOR FROM PATIENT'S VAGINA, IT CAME APART. ALL PIECES WERE LOCATED AND ACCOUNTED FOR. CURRENT LOT CODES IN HOUSE: 1111011; 1110251; 1107251; 1108312; 1103011; 1106152; 1103291; 1107121." THE DEVICE WAS REPORTED AS A DEVICE TYPE OF UTERINE MANIPULATOR WITH CATALOG NUMBER OF 60-6086-100. THERE IS NO MENTION IN THE MAUDE REPORT OF ANY PATIENT INJURY ASSOCIATED WITH THIS MALFUNCTION OF THE DEVICE .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1