BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM

    MDR report key: 2973939 · Received February 22, 2013

    Report

    Report Number
    1320894-2013-00020
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HAS BEEN DISCARDED BY THE END-USER FACILITY; THEREFORE, NO DEVICE EVALUATION WILL BE ACCOMPLISHED. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE DISCARDED BY END-USER.

    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 LOT 1212171 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. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE SPECIFIC FAILURE MODE AND ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE. THEREFORE, THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. 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, "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." AND "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. MORCELATION 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 HAVE BEEN RETRIEVED FROM THE PATIENT." THE IFU FURTHER WARNS, "FAILURE TO SEPARATE THE CERVICAL CUP FROM THE TISSUE MAY RESULT IN DETACHMENT OF THE CERVICAL CUP AND / OR PATIENT INJURY". WITHOUT EXAMINATION OF THE ACTUAL DEVICE, THERE IS NO CONCLUSIVE PROOF THAT THE SUSPECT DEVICE FAILED TO MEET SPECIFICATIONS DURING THE PROCEDURAL TREATMENT OF THE PATIENT, A ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY. THE SUSPECT DEVICE IS NOT CONCLUSIVELY AT FAULT FOR THE INCIDENT, THE INCIDENT HAS BEEN DETERMINED MOST PROBABLY 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. DISCARDED BY END-USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CONMED THAT, "NURSE MANAGER CALLED REP AND INFORMED ME THAT THE VCARE YESTERDAY BROKE INTO PIECES. NO PRODUCT NUMBER, NO ADDITIONAL INFORMATION. REP PHONED TO REPORT THIS WAS A VCARE MEDIUM AND THE LOT 1212171." IT WAS ALSO REPORTED THAT ALL PIECES WERE RETRIEVED, AND, NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78336 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 1212171

    Patients

    Seq Age Sex Outcome Treatment
    1