BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    MDR report key: 2212500 · Received August 16, 2011

    Report

    Report Number
    1320894-2011-00064
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    March 12, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS PREVIOUSLY CLOSED BY CONMED ON (B)(4) 2011. SUBSEQUENT TO CLOSING THIS COMPLAINT THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RETURNED TO CONMED BY THE END-USER. THIS DEVICE WAS DELIVERED TO CONMED ON (B)(4) 2012. FOLLOWS IS THE EVALUATION OF THE RETURNED DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO CONMED CORPORATION FOR EVALUATION WITH THE CERVICAL CONE AND THE UTERINE BALLOON (PARTIAL) COMPLETELY DETACHED FROM THE DEVICE. ONLY THE CERVICAL CONE AND WHAT APPEARED TO BE A PIECE OF THE PROXIMAL END OF THE INTRAUTERINE BALLOON AND A SMALL PIECE OF SUTURE WERE RETURNED TO CONMED CORPORATION. THE CENTER HOLE IN THE CERVICAL CONE MEASURED WITHIN SPECIFICATIONS USING CALIBRATED PIN GAGE. THE PIECE OF INTRAUTERINE BALLOON APPEARED TO BE TORN FROM THE PROXIMAL END, INDICATING THAT THE BALLOON WAS ORIGINALLY SECURELY ATTACHED TO THE MANIPULATOR TUBE. AN "INVESTIGATION GUIDANCE" QUESTIONNAIRE WAS COMPLETED FOR THIS COMPLAINT BY THE END-USER FACILITY. NO PROBLEMS WITH THE DEVICE WERE IDENTIFIED AND THERE WERE NO KNOWN IDENTIFIABLE CAUSES. CERTAIN SPECIFIC INFORMATION RELATED TO THE USE OF THE DEVICE WERE UNKNOWN, INCLUDING WHETHER SUCTION BETWEEN THE CERVICAL CUP AND CERVIX WAS BROKEN OR WHETHER THE BLUE VAGINAL CUP WAS RETRACTED PRIOR TO REMOVAL OF THE DEVICE. THE QUESTIONNAIRE NOTED THAT THE UTERINE BALLOON WAS NOT DEFLATED AT THE TIME OF FAILURE AND EXCESSIVE FORCE WAS NOT REQUIRED TO REMOVE THE DEVICE. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT INSPECTED FOR COMPLETENESS UPON REMOVAL PER THE DFU, DIRECTIONS FOR USE. THE SPECIFIC CAUSE OF THE DETACHMENT OF COMPONENTS REMAINS UNDETERMINED. THE MOST LIKELY CAUSE OF THIS COMPLAINT 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 AND VAGINAL CONE. USER TECHNIQUE MAY HAVE BEEN A CONTRIBUTING FACTOR. 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 DEVICE'S DFU 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 THUMBSCREW) HAVE BEEN REMOVED FROM THE PATIENT." THE DEVICE EXAMINATION HAS NOT IDENTIFIED A MANUFACTURING DEFECT; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THE PRESENT TIME. CONMED CORPORATION IS AGAIN CONSIDERING THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE INCIDENT DUE TO SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2011-00062. PACKAGING WITH LOT# AND SERIAL# AND DEVICE WERE DISCARDED IMMEDIATELY POST-IT; THEREFORE, AN EVALUATION OF THE SUSPECT DEVICE WILL NOT BE CONDUCTED. WHEN THE QUALITY ENGINEERING EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. THIS IS ASSOCIATED WITH MAUDE EVENT REPORT (B)(4). DEVICE PART DISCARDED PART WITH FACILITY.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN. THEREFORE, DHR REVIEW WAS NOT PERFORMED. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE SPECIFIC FAILURE MODE AND ASSOCIATED ROOT CAUSE CANNOT BE DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE. IF THE DEVICE IS RETURNED IN THE FUTURE, THIS COMPLAINT INVESTIGATION MAY BE REOPENED AND FURTHER INVESTIGATION PERFORMED. AN "INVESTIGATION GUIDANCE" QUESTIONNAIRE WAS COMPLETED BY THE END-USER FOR THIS COMPLAINT. NO PROBLEMS WITH THE DEVICE WERE IDENTIFIED AND THERE WERE NO KNOWN IDENTIFIABLE CAUSES. CERTAIN SPECIFIC INFORMATION RELATED TO THE USE OF THE DEVICE WAS UNKNOWN, INCLUDING WHETHER SUCTION BETWEEN THE CERVICAL CUP AND CERVIX WAS BROKEN OR WHETHER THE BLUE VAGINAL CUP WAS RETRACTED PRIOR TO REMOVAL OF THE DEVICE. THE QUESTIONNAIRE NOTED THAT THE UTERINE BALLOON WAS NOT DEFLATED AT THE TIME OF FAILURE AND EXCESSIVE FORCE WAS NOT REQUIRED TO REMOVE THE DEVICE. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT INSPECTED FOR COMPLETENESS UPON REMOVAL PER DFU, DIRECTIONS FOR USE. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR THE VCARE PRODUCT FAMILY SHOWED 53 PREVIOUS COMPLAINTS WHERE THE CERVICAL CONE AND/OR UTERINE BALLOON WERE REPORTED DETACHED. OF THESE, 26 WERE CONFIRMED, 21 INCONCLUSIVE (DEVICE NOT RETURNED), 6 NO INVESTIGATION. THE SPECIFIC CAUSE OF THE DETACHMENT OF COMPONENTS WAS UNDETERMINED. THE LIKELY CAUSE OF THIS INCIDENT IS USER TECHNIQUE AND 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, PARTIALLY DETACHING THE UTERINE BALLOON FROM THE DEVICE. 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. THE RISK ASSOCIATED WITH THIS COMPLAINT IS MITIGATED IN CURRENT DFU 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 THUMBSCREW) HAVE BEEN REMOVED FROM THE PATIENT." THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED A MANUFACTURING OR COMPONENT DEFECT; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THE PRESENT TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. (B)(4). NOT RETURNED TO CONMED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PT WAS HAVING A SUPRACERVICAL HYSTERECTOMY USING THE DAVINCI SURGICAL ROBOT. PART OF THE SURGICAL SET-UP INCLUDED THE CONMED VCARE UTERINE MANIPULATOR. AT THE END OF THE CASE, MD DID NOT CHECK THE SURGICAL FIELD. PT CAME INTO MD'S OFFICE IN (B)(6), AND WHEN DOING A VAGINAL EXAM, MD FOUND GREEN CUP FROM END OF THE VAGINAL MANIPULATOR. IT ALSO APPEARS THAT PART OF THE DEFLATED BALLOON IS STUCK TO THE INTERIOR OF THE CUP. CUP BROUGHT TO RISK MANAGEMENT OFFICE BY (B)(6). PACKAGING WITH LOT# AND SERIAL# AND DEVICE WERE DISCARDED IMMEDIATELY POST-IT. IT WAS NOT NOTICED UNTIL PATIENT'S FOLLOW UP VISIT THAT ANYTHING WAS WRONG WITH THE PROCEDURE OR MANIPULATOR." THERE IS NO MENTION OF PATIENT INJURY ASSOCIATED WITH 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1