BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, SMALL

    MDR report key: 3477601 · Received November 19, 2013

    Report

    Report Number
    1320894-2013-00121
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 21, 2013
    Report Date
    February 12, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2012-00099. THE DEVICE HAS NOT YET BEEN RETURNED TO CONMED CORPORATION; HOWEVER, THE RETURN IS ANTICIPATED. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED. THE ATTACHED MEDWATCH DOES NOT HAVE A FACILITY NUMBER; HOWEVER, THE END-USER FACILITY STATES THAT THE ATTACHED WAS MAILED TO THE FDA. NOT YET RETURNED TO MANUFACTURER.

    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. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR LOT 1210011 HAS VERIFIED THE DEVICES WERE PRODUCED AND RELEASED ACCORDING TO THE CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. PROPER MANUFACTURING PROCEDURES INCLUDING TESTING AND INSPECTIONS WERE PERFORMED DURING MANUFACTURE TO PREVENT NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS AND PERFORMANCE. COMMUNICATIONS WERE ATTEMPTED WITH THE END-USER FACILITY FOR THE RETURN OF THE DEVICE FOR EVALUATION; HOWEVER, THESE COMMUNICATIONS HAVE REMAINED UNANSWERED TO DATE. THEREFORE, A DEVICE EVALUATION WAS NOT CONDUCTED. A POTENTIAL CAUSE OF THIS COMPLAINT IS APPLICATION OF FORCE DURING MANIPULATION OF THE DEVICE WHICH EXCEEDED THE CERVICAL CONE PULL OFF STRENGTH CAPABILITY. A CONTRIBUTING FACTOR MAY HAVE BEEN NOT UNLOCKING THE LOCKING MECHANISM AND RETRACTING THE VAGINAL CONE PRIOR TO REMOVAL OF THE DEVICE. THIS FACTOR WOULD INCREASE RESISTANCE ALLOWING THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE. THE RISK ASSOCIATED WITH THIS COMPLAINT IS MITIGATED IN THE IFU, INSTRUCTIONS FOR USE, WHICH STATES, "PRIOR TO REMOVAL OF THE DEVICE, ENSURE THE LOCKING MECHANISM IS RELEASED VIA THE THUMBSCREW AND SWIPE A FINGER AROUND THE EDGE OF THE VAGINAL CUP TO SEPARATE THE TISSUE FROM THE CUP TO PREVENT TISSUE DAMAGE. DO NOT USE EXCESSIVE FORCE UPON DEVICE REMOVAL TO AVOID TRAUMATIZING THE VAGINAL CANAL AND/OR COMPONENT DETACHMENT. VAGINAL DELIVERY OF A LARGE UTERUS MAY RESULT IN PATIENT INJURY. MORCELLATION OR OTHER METHODS SHOULD BE USED TO REDUCE THE SIZE OF THE UTERUS PRIOR TO REMOVAL THROUGH THE VAGINAL CANAL. VISUALLY INSPECT VCARE ON REMOVAL FROM THE PATIENT TO VERIFY THAT THE DEVICE IS INTACT AND ALL FORWARD COMPONENTS (FIGURE #1: 1. INTRAUTERINE BALLOON, 2. CERVICAL CUP, 3. VAGINAL CUP, 4. LOCKING ASSEMBLY AND 5. THUMBSCREW) HAVE BEEN RETRIEVED FROM THE PATIENT." THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE INCIDENT IS MOST PROBABLY END-USER RELATED. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED A MANUFACTURING OR COMPONENT DEFECT AND THE MALFUNCTION HAS BEEN DETERMINED AS USE RELATED; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THE PRESENT TIME. CONMED CORPORATION IS CONSIDERING THIS COMPLAINT CLOSED. NOT RETURNED TO CONMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CONMED THAT, "DURING REMOVAL OF A SMALL VAGINAL CERVICAL RETRACTOR ELEVATOR FROM THE PATIENT'S VAGINA IT CAME APART IN 4 PIECES." IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY AND ALL FOUR (4) PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600130 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, SMALL VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 1210011

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR