BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCARE 200A - MEDIUM

    MDR report key: 18747534 · Received February 21, 2024

    Report

    Report Number
    1320894-2024-00038
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 12, 2024
    Report Date
    February 29, 2024
    Manufacturer
    CONMED UTICA
    Product Code
    LKF
    PMA / PMN Number
    K142716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. 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. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (5150552) RECEIVED ON 2FEB24. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-201A, VCARE 200A - MEDIUM. THE REPORT STATES THAT ON (B)(6) 2024 THE ¿VCARE INSTRUMENT BROKE OFF INSIDE OF PATIENT WHILE BEING UTILIZED.¿ ASSESSMENT QUESTIONS COULD NOT BE SENT AS THE REPORTER ELECTED TO REMAIN ANONYMOUS. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FRAGMENTATION LEFT IN THE PATIENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (5150552) RECEIVED ON 2FEB24. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-201A, VCARE 200A - MEDIUM. THE REPORT STATES THAT ON (B)(6) 2024 THE "VCARE INSTRUMENT BROKE OFF INSIDE OF PATIENT WHILE BEING UTILIZED." ASSESSMENT QUESTIONS COULD NOT BE SENT AS THE REPORTER ELECTED TO REMAIN ANONYMOUS. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FRAGMENTATION LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89401 VCARE 200A - MEDIUM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED UTICA 202305011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other