BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    MDR report key: 2760042 · Received September 26, 2012

    Report

    Report Number
    1320894-2012-00099
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 4, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN POSSESSION OF RISK MANAGEMENT DEPARTMENT, AT (B)(6) MEDICAL CENTER. CONMED IS ASKING FOR RETURN OF THE DEVICE. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE NOT RETURNED FOR EVALUATION.

    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. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR LOT 1110251 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. A VCARE CONE / BALLOON DETACHMENT INVESTIGATION GUIDANCE QUESTIONNAIRE WAS SENT TO END-USER FOR COMPLETION RELATED TO THIS COMPLAINT. THE SURVEY WAS NEVER RETURNED TO CONMED, AND, ALL ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS EVENT REMAIN UNANSWERED. THE ENTIRE ACTUAL SUSPECT DEVICE IN THIS REPORTED INCIDENT NOT AVAILABLE FOR EVALUATION. THE CERVICAL CUP WOULD HAVE BEEN RETRIEVED ONE WEEK POST-OP; HOWEVER, WITHOUT THE REMAINDER OF THE DEVICE THE INVESTIGATION WOULD BE INCONCLUSIVE. THE SPECIFIC FAILURE MECHANISM AND ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ENTIRE ACTUAL DEVICE. THE SPECIFIC FAILURE, FAILURE MECHANISM, AND ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ENTIRE ACTUAL DEVICE. FOR THESE REASONS, CONMED DID NOT PURSUE THE RETURN OF THE PARTIAL DEVICE FROM THE END-USER FACILITY. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS APPLICATION OF FORCE WHICH EXCEEDED THE CERVICAL CONE PULL OFF STRENGTH CAPABILITY OF THE DEVICE. THIS WOULD ALLOW THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE, TEARING THE INTRA-UTERINE BALLOON. CONTRIBUTING FACTORS INCLUDE NOT RELEASING THE LOCKING MECHANISM PRIOR TO REMOVAL ATTEMPT, AND NOT RETRACTING THE BLUE VAGINAL CONE PRIOR TO REMOVING THE DEVICE. THESE FACTORS WOULD INCREASE RESISTANCE ALLOWING THE VCARE SHAFT TO PULL THROUGH THE CERVICAL CONE. RETRACTING THE VAGINAL CONE IN THE VAGINAL CAVITY PRIOR TO DEVICE REMOVAL MAY ALLOW FOR AN EASIER REMOVAL OF THE DEVICE. A SMALL VAGINAL CAVITY, THE PARTICULAR SHAPE OF THE VAGINAL CANAL, OR VAGINAL CANAL ANATOMICAL CHANGES MAY ALSO INCREASE REMOVAL FORCE ON THE DEVICE IF THE VAGINAL CONE IS NOT REMOVED PROPERLY PER DFU, DIRECTIONS FOR USE, INSTRUCTIONS. THE RISK ASSOCIATED WITH THIS COMPLAINT IS MITIGATED IN THE VCARE DFU WHICH STATES, " VISUALLY INSPECT VCARE ON REMOVAL FROM THE PATIENT TO VERIFY THAT THE DEVICE IS INTACT AND ALL FORWARD COMPONENTS (FIGURE #1: 1. INTRAUTERINE BALLOON, 2. CERVICAL CUP, 3. VAGINAL CUP, 4. LOCKING ASSEMBLY AND 5. THUMBSCREW) HAVE BEEN RETRIEVED FROM THE PATIENT." 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, "A PATIENT COMPLAINED OF ABDOMINAL PAIN APPROXIMATELY ONE (1) WEEK POST OP, AFTER HER SURGERY. UPON INSPECTION BY HER PHYSICIAN, A VCARE CUP WAS RETRIEVED FROM HER VAGINA." FURTHER RECEIVED INFORMATION STATED THAT THE ORIGINAL PROCEDURE WAS A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 1110251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other