BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE 200A - MEDIUM

    MDR report key: 14114627 · Received April 14, 2022

    Report

    Report Number
    1320894-2022-00075
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 3, 2022
    Manufacturer
    CONMED UTICA
    Product Code
    LKF
    UDI-DI
    10653405003793
    PMA / PMN Number
    K142716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE ROOT CAUSE CANNOT BE IDENTIFIED. 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. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND A TOTAL OF 2 SIMILAR EVENTS INVOLVING 2 DEVICES FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 70 COMPLAINTS, REGARDING 85 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 659,592 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED 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.SWIPE A FINGER AROUND THE EDGE OF THE VAGINAL CUP TO SEPARATE THE TISSUE FROM THE CUP TO PREVENT TISSUE DAMAGE.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. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-201A, VCARE 200A - MEDIUM, WAS BEING USED DURING A TOTAL LAP HYSTERECTOMY ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿A MEDIUM VCARE WAS INSERTED INTO PATIENT FOR UTERUS MANIPULATION. DURING THE PROCEDURE, THE HANDLE OF THE VCARE BROKE. THE SURGEON STOPPED THE PROCEDURE, REMOVED THE BROKEN VCARE.¿ FURTHER ASSESSMENT QUESTIONING FOUND; DR. SARAH FERGUSON WAS USING A ¿MEDIUM VCARE TO MANIPULATE THE UTERUS DURING THE PROCEDURE. WHEN THE SURGEON TRIED TO REMOVE THE VCARE FROM THE PATIENT'S VAGINA - AFTER THEY DETACHED THE VAGINA FROM THE CERVIX - THE GREEN CUP AND THE BALLOON BROKE OFF OF THE VCARE HANDLE. THE DEVICE FRAGMENTED WHILE IN THE SURGICAL SITE BUT WAS RETRIEVED BY AN INSTRUMENT THAT WAS INSERTED VAGINALLY TO REMOVE THE COMPONENT¿. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY, NO OTHER MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AT THE TIME, AND ¿IT IS UNKNOWN IF THE PATIENT REQUIRED AN EXTENDED STAY AT THE HOSPITAL. IT IS ASSUMED THE PATIENT WAS DISCHARGED HOME¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-201A, VCARE 200A - MEDIUM, WAS BEING USED DURING A TOTAL LAP HYSTERECTOMY ON 29MAR22 WHEN IT WAS REPORTED, ¿A MEDIUM VCARE WAS INSERTED INTO PATIENT FOR UTERUS MANIPULATION. DURING THE PROCEDURE, THE HANDLE OF THE VCARE BROKE. THE SURGEON STOPPED THE PROCEDURE, REMOVED THE BROKEN VCARE.¿ FURTHER ASSESSMENT QUESTIONING FOUND; DR. SARAH FERGUSON WAS USING A ¿MEDIUM VCARE TO MANIPULATE THE UTERUS DURING THE PROCEDURE. WHEN THE SURGEON TRIED TO REMOVE THE VCARE FROM THE PATIENT'S VAGINA - AFTER THEY DETACHED THE VAGINA FROM THE CERVIX - THE GREEN CUP AND THE BALLOON BROKE OFF OF THE VCARE HANDLE. THE DEVICE FRAGMENTED WHILE IN THE SURGICAL SITE BUT WAS RETRIEVED BY AN INSTRUMENT THAT WAS INSERTED VAGINALLY TO REMOVE THE COMPONENT¿. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY, NO OTHER MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AT THE TIME, AND ¿IT IS UNKNOWN IF THE PATIENT REQUIRED AN EXTENDED STAY AT THE HOSPITAL. IT IS ASSUMED THE PATIENT WAS DISCHARGED HOME¿. 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
    190785 VCARE 200A - MEDIUM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED UTICA 60-6085-201A 202201101 10653405003793

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female