BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, UNKNOWN SIZE

    MDR report key: 4895457 · Received July 7, 2015

    Report

    Report Number
    1320894-2015-00014
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    February 11, 2015
    Report Date
    June 8, 2015
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS DISCOVERED ON THE RECEIPT OF A MEDWATCH FORWARDED TO CONMED FROM THE US FDA. THIS EVENT WAS NEVER REPORTED TO CONMED BY THE END-USER FACILITY. THE RISK MANAGER WAS CONTACTED AND RECEIVED INFORMATION INDICATED THAT THE DEVICE WAS DISCARDED AT THE ORIGINAL SURGERY, AND, THE DEVICE COMPONENT THAT WAS ALLEGEDLY RETAINED AND SUBSEQUENTLY REMOVED WAS ALSO DISCARDED BY THE END-USER FACILITY. THE INVOLVED DEVICE WAS NOT AVAILABLE FOR EVALUATION AND THUS IT CANNOT BE VERIFIED THAT THE "1CM PIECE OF SOFT PLASTIC" DISCOVERED DURING THE BOWEL SURGERY CAME FROM A CONMED DEVICE WITHOUT EXAMINING THE DEVICE FRAGMENT. THE REPORTED "RETAINED FOREIGN OBJECT ALLEGEDLY CAME FROM THE NECK OF THE BALLOON ON VAGINAL MANIPULATOR" THEREFORE CANNOT BE CONFIRMED AND THE SPECIFIC FAILURE MODE AS WELL AS ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE. A REVIEW OF THE DHR COULD NOT BE PERFORMED, AS THE DEVICE CATALOG ITEM AND/OR LOT NUMBER WAS NOT PROVIDED. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF (B)(4) SIMILAR REPORTS OF VCARE COMPONENT SEPARATION INSIDE THE PATIENT. DURING THIS SAME 2-YEAR TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS FAILURE MODE (B)(4). IT SHOULD BE NOTED, OF THE (B)(4) REPORTS OF COMPONENT DETACHMENTS, THERE HAS BEEN ONLY (B)(4) REPORT IN WHICH A SECOND SURGERY WAS PERFORMED TO REMOVE THE RETAINED FOREIGN OBJECTS. IT SHOULD BE NOTED THAT THIS REPORTED EVENT WAS NOT A PLANNED SURGICAL PROCEDURE TO RETRIEVE A DEVICE FRAGMENT, BUT THAT THE FRAGMENT WAS DISCOVERED DURING A ROUTINE SURGICAL PROCEDURE FOR A BOWEL OBSTRUCTION. TO DATE, THERE HAVE BEEN NO PATIENT LONG TERM ADVERSE EFFECTS REPORTED REGARDING ANY OF THE REPORTED INCIDENTS. THE VCARE UTERINE MANIPULATOR 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. TO REDUCE THE RISK OF COMPONENT DETACHMENT AND PATIENT INJURY, THE INSTRUCTION FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: PRIOR TO REMOVAL OF THE DEVICE, ENSURE THE LOCKING MECHANISM IS RELEASED VIA THE THUMBSCREW AND SWIPE A FINGER AROUND THE EDGE OF THE VAGINAL CUP TO SEPARATE THE TISSUE FROM THE CUP TO PREVENT TISSUE DAMAGE. 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 ALL BEEN RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, CONMED RECEIVED THE USER VOLUNTARY MEDWATCH REPORT #5200980000-2015-8013 FORWARDED BY THE FDA. LISTED BELOW IS THE INFORMATION AS PROVIDED ON THE MEDWATCH REPORT. "PATIENT UNDERWENT A LAPAROSCOPIC ROBOTIC HYSTERECTOMY. DISCHARGED HOME AND RETURNED FOR A SECOND ADMISSION. DURING A SECOND SURGERY A 1CM PIECE OF SOFT PLASTIC FROM NECK OF BALLOON ON VAGINAL MANIPULATOR WAS FOUND TO BE RETAINED IN THE PATIENT. UPON INVESTIGATION, PIECE WAS NOTED TO BE TORN FROM BALLOON. CERVICAL CUFF HAD BEEN RETAINED AND REMOVED DURING ORIGINAL PROCEDURE. IT IS BELIEVED THAT TRACTION AGAINST CERVICAL CUP WHILE REMOVING VAGINAL MANIPULATOR DURING ORIGINAL PROCEDURE CAUSED TEAR AND RETAINED PIECE. IT IS NOT KNOWN CONCLUSIVELY THAT THE RETAINED PIECE CAUSED HARM TO THE PATIENT WHO ALSO HAD A SMALL BOWEL OBSTRUCTION WITH ABSCESS." FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION FOR IT WAS DISPOSED OF AFTER THE ORIGINAL SURGERY. THE RETRIEVED DEVICE FRAGMENT IS ALSO NOT AVAILABLE FOR IDENTIFICATION AS IT HAS BEEN DISCARDED BY THE END-USER FACILITY AFTER THE SECOND SURGERY. THE RISK MANAGER WAS UNAWARE OF THE DEVICE CATALOG NUMBER AND/OR LOT NUMBER AND SHE ALSO WAS UNAWARE OF THE PATIENT'S WEIGHT. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR INDICATION THAT ANY LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437647 VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, UNKNOWN SIZE VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other