BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE 200A - MEDIUM

    MDR report key: 10881084 · Received November 21, 2020

    Report

    Report Number
    1320894-2020-00513
    Event Type
    Malfunction
    Date Received
    November 21, 2020
    Date of Event
    October 9, 2020
    Report Date
    January 29, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K142716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 60-6085-201A OPENED IN UNORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION ON DEVICE, V-CARE RETURNED WITH GREEN MEDIUM CERVICAL CUP AND UTERINE BALLOON COMPLETELY OFF THE PRINTED V-CARE TUBE. UV ADHESIVE PEELING OFF PRINTED TUBE. VAGINAL CUP SHOULD BE FULLY RETRACTED TO THE HANDLE PRIOR TO REMOVAL OF DEVICE. IF AXIAL FORCE (PULL) APPLIED TO DEVICE DURING REMOVAL OF V-CARE EXCEEDS RETENTION LIMITS, THE EXCESSIVE FORCE CAN CAUSE V-CARE PARTS TO COME OFF DEVICE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 67 COMPLAINTS, REGARDING 83 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO RE-ATTACH THE SYRINGE TO THE LUER CONNECTOR AT THE END OF THE PILOT BALLOON; FULLY ASPIRATE THE AIR FROM THE INTRAUTERINE BALLOON TO DEFLATE. THIS WILL ALLOW THE INTRAUTERINE BALLOON TO BE REMOVED FROM THE UTERUS. UNLOCK THE LOCKING MECHANISM BY TURNING THE THUMBSCREW COUNTER-CLOCKWISE (ANTI-CLOCKWISE) AND RETRACT TO THE HANDLE. A. SWIPE A 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. CAREFULLY REMOVE THE DEVICE FROM THE VAGINA. DO NOT USE EXCESSIVE FORCE TO AVOID TRAUMATIZING THE VAGINAL CANAL. UPON REMOVING VCARE, THE SURGEON SHOULD VISUALLY INSPECT THE VCARE DEVICE, AND THE PATIENT, TO MAKE SURE THAT THE ENTIRE VCARE DEVICE WAS PROPERLY REMOVED AND THAT NO COMPONENTS OR FRAGMENTS OF THESE COMPONENTS WERE RETAINED IN THE PATIENT. THERE ARE 5 PARTS/COMPONENTS TO THE VCARE CERVICAL ELEVATOR RETRACTOR. THESE ARE: 1) THE BALLOON; 2) THE FORWARD "CERVICAL" CUP; 3) THE BACK OR VAGINAL CUP; 4) THE LOCKING ASSEMBLY WITH THUMB SCREW; 5) THE METAL SHAFT AND HANDLE WITH BALLOON INFLATION VALVE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, 60-6085-201A, WAS BEING USED DURING A PROCEDURE ON (B)(6) 2020 WHEN THE DEVICE WAS REPORTED AS "MISMATCHING OF THE GREEN RING AND THE BALLOON OF THE VCARE AT THE END OF SURGERY". FURTHER ASSESSMENT FOUND THAT THE DEVICE HAD BROKEN IN THE PATIENT AND ALL THE PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DELAY; HOWEVER, THE AMOUNT OF DELAY TIME WAS NOT REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346253 VCARE 200A - MEDIUM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED CORPORATION 201903111

    Patients

    Seq Age Sex Outcome Treatment
    1