BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, LARGE

    MDR report key: 2820298 · Received November 6, 2012

    Report

    Report Number
    1320894-2012-00105
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 24, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2012-00099. THE DEVICE RETURN IS ANTICIPATED; HOWEVER, HAS NOT YET BEEN RECEIVED BY CONMED CORPORATION. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED. RETURN ANTICIPATED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED AS DATE RECEIVED BY MANUFACTURER AS (B)(4) 2012. THE CORRECT DATE RECEIVED BY MANUFACTURER IS (B)(4) 2012.

    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 SHOWED THAT THIS LOT WAS CONFIRMED BY MANUFACTURING DOCUMENTATION TO HAVE BEEN PRODUCED ACCORDING TO MANUFACTURING SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. ONE (1) VCARE DEVICE WAS RETURNED FOR EVALUATION. THE CERVICAL CONE WAS COMPLETELY DETACHED FROM THE MANIPULATOR TUBE, BUT THE INTRAUTERINE BALLOON AND VAGINAL CONE WERE STILL ATTACHED. THE PROXIMAL END OF THE INTRAUTERINE BALLOON HAD BEEN PUSHED JUST OVER THE SHRINK BAND. THE U.V. ADHESIVE APPEARED TO HAVE BEEN ADEQUATELY APPLIED TO THE MANIPULATOR TUBE WHERE THE INTRAUTERINE BALLOON WAS ATTACHED. THE INSIDE DIAMETER OF THE CERVICAL CONE MEASURED WITHIN SPECIFICATION USING CALIBRATED PIN GAGES. THE OUTSIDE DIAMETER OF SHRINK BAND PROVIDED AN INTERFERENCE FIT BETWEEN THE INSIDE DIAMETER OF THE CERVICAL CONE WITH THE OUTSIDE DIAMETER OF THE SHRINK BAND ON THE MANIPULATOR TUBE. THE INTRAUTERINE BALLOON ADDS ADDITIONAL RESISTANCE TO DETACHMENT OF THE CERVICAL CONE. A VCARE CONE / BALLOON DETACHMENT INVESTIGATION GUIDANCE QUESTIONNAIRE WAS SENT TO END-USER FOR COMPLETION RELATED TO THIS COMPLAINT. KEY INFORMATION FROM THE QUESTIONNAIRE INCLUDES THE FOLLOWING: THIS WAS A ROBOTIC ASSISTED LAVH, LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, WHERE THE UTERUS WAS REMOVED VAGINALLY. ADDITIONAL INFORMATION FROM THE INVESTIGATION GUIDE INCLUDE THAT THE DEVICE WAS NOT DIFFICULT TO REMOVE. AT THE TIME OF FAILURE THE LOCKING MECHANISM WAS NOT RELEASED AND THE BLUE VAGINAL CONE WAS NOT RETRACTED PRIOR TO ATTEMPTING TO REMOVE THE DEVICE. A POTENTIAL CAUSE OF THIS COMPLAINT IS APPLICATION OF FORCE DURING MANIPULATION OF THE DEVICE WHICH EXCEEDED ITS CERVICAL CONE PULL OFF STRENGTH CAPABILITY. A CONTRIBUTING FACTOR MAY HAVE BEEN NOT RELEASING THE LOCKING MECHANISM AND RETRACTING THE THE BLUE VAGINAL CONE PRIOR TO REMOVING THE DEVICE. THIS WOULD INCREASE RESISTANCE AND ALLOW THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE. THE RISK ASSOCIATED WITH THIS COMPLAINT IS MITIGATED IN THE DFU, DIRECTIONS FOR USE, WHICH STATES, "UNLOCK THE LOCKING MECHANISM BY TURNING THE THUMBSCREW COUNTERCLOCKWISE (ANTICLOCKWISE) AND RETRACT TO THE HANDLE. A. SWIPE FINGER AROUND THE EDGE OF THE VAGINAL CUP TO SEPARATE THE TISSUE FROM THE CUP TO PREVENT TISSUE DAMAGE. B. FULLY RETRACT THE VAGINAL CUP TO THE HANDLE". 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.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING A ROBOTIC PROCEDURE WHEN REMOVING THE DEVICE FROM PATIENT THE GREEN CUP CAME OFF THE MANIPULATOR. NOT SURE IF THE CUP WAS STILL SUTURED AT THE TIME OF REMOVAL BUT WAS NOT WHEN RETRIEVED FROM PATIENT.." IT WAS ALSO REPORTED, "NO INJURY TO PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, LARGE VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 1207091

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR