BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    MDR report key: 2211257 · Received August 15, 2011

    Report

    Report Number
    1320894-2011-00063
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    September 13, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE INCIDENT DUE TO SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2011-00062. THE VCARE DEVICE IS BEING RETURNED TO CONMED CORPORATION BY THE END-USER; HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED TO DATE. WHEN THE QUALITY ENGINEERING EVALUATION / INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. NOT YET RECEIVED FROM END-USER.

    Additional Manufacturer Narrative · 1

    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. THERE WAS NO NCR, NON-CONFORMING REPORT, IN THE DHR RECORD. ONE (1) ORIGINAL COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE CERVICAL CONE AND UTERINE BALLOON WERE COMPLETELY DETACHED FROM THE MANIPULATOR TUBE CONFIRMING THE COMPLAINT. THE RIM OF THE CERVICAL CONE HAD SUSTAINED MINOR DAMAGE; APPARENTLY FROM CONTACT WITH A SURGICAL INSTRUMENT. THE UTERINE BALLOON APPEARED TO HAVE BEEN "PEELED" OVER THE SHRINK TUBING. EXAMINATION UNDER A MICROSCOPE SHOWED THAT A ADEQUATE AMOUNT OF ADHESIVE HAD BEEN APPLIED TO THE UTERINE BALLOON AS WELL AS THE MANIPULATOR TUBE. THE LOCK COLLAR/SCREW WAS UNLOCKED ON THE MANIPULATOR TUBE. THE INSIDE DIAMETER OF THE CERVICAL CONE MEASURED TO BE WITHIN SPECIFICATIONS USING CALIBRATED PIN GAGES. AN INTERFACE FIT WAS NOTED BETWEEN THE INSIDE DIAMETER OF THE CERVICAL CONE AND THE SHRINK BAND ON THE MANIPULATOR TUBE. NO MANUFACTURING DEFECTS OR PART DEFECTS WERE EVIDENT. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR THE VCARE PRODUCT FAMILY SHOWED 50 PREVIOUS COMPLAINTS WHERE THE CERVICAL CONE AND/OR UTERINE BALLOON WERE REPORTED DETACHED. OF THESE, 23 WERE CONFIRMED, 19 INCONCLUSIVE (DEVICE NOT RETURNED), 6 NO INVESTIGATION, AND 2 PENDING INVESTIGATION. NUMEROUS ATTEMPTS WERE MADE TO TRY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT WITH NO RESPONSE FROM THE END-USER FACILITY TO ANY ATTEMPTED COMMUNICATIONS. THE CAUSE OF THE DETACHMENT OF COMPONENTS WAS UNDETERMINED. THE POSSIBLE CAUSE IS APPLICATION OF FORCE WHICH EXCEEDED THE CERVICAL CONE/UTERINE BALLOON PULL OFF STRENGTH CAPABILITY OF THE DEVICE. THIS WOULD ALLOW THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE, DETACHING THE UTERINE BALLOON FROM THE DEVICE. USER TECHNIQUE MAY HAVE BEEN A CONTRIBUTING FACTOR. BREAKING THE SUCTION BETWEEN THE CERVICAL CONE AND THE CERVIX, AND RETRACTING THE VAGINAL CONE IN THE VAGINAL CAVITY, MAY ALLOW 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. THE RISK ASSOCIATED WITH THIS COMPLAINT IS MITIGATED IN CURRENT IFU 14071, REVISION C, WHICH STATES, "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 THUMB SCREW) HAVE BEEN REMOVED FROM THE PATIENT." THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED A MANUFACTURING DEFECT; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DA VINCI CASE WHERE THE CUP FELL OFF AND THE BALLOON DETACHED FROM THE SHAFT. NEVER HAD THIS PROBLEM BEFORE. HAD TO OPEN A SECOND VCARE TO FINISH THE CASE". IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR VCARE UTERINE MANIPULATOR, STANDARD SIZE LKF CONMED CORPORATION 1104062

    Patients

    Seq Age Sex Outcome Treatment
    1