BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, LARGE

    MDR report key: 3305224 · Received August 23, 2013

    Report

    Report Number
    1320894-2013-00073
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    May 20, 2013
    Report Date
    November 11, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THIS COMPLAINT WAS DISCOVERED ON THE RECEIPT OF MEDWATCH REPORT NUMBER (B)(4) FROM THE FDA ON (B)(4) 2013. THE DEVICE IS STATED AS AVAILABLE FOR EVALUATION. CONMED IS ATTEMPTING TO REACH THE MEDWATCH INITIAL REPORTER TO INQUIRE ABOUT RETURN OF THE SUSPECT DEVICE TO CONMED CORPORATION FOR A QUALITY ENGINEERING EVALUATION. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE NOT RETURNED TO CONMED CORP.

    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 1211201 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. 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: INTRAUTERINE BALLOON, CERVICAL CUP, VAGINAL CUP, LOCKING ASSEMBLY AND THUMBSCREW) 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 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. NEVER RETURNED TO CONMED CORPORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "LARGE V-CARE UTERINE MANIPULATOR CAME APART WHILE REMOVING THE UTERUS FROM THE VAGINA. NO HARM TO PATIENT OR STAFF." THIS OCCURRED DURING A HYSTERECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413320 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, LARGE VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 1211201

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR