BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE 200A - MEDIUM

    MDR report key: 12513865 · Received September 22, 2021

    Report

    Report Number
    1320894-2021-00363
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 21, 2021
    Manufacturer
    CONMED UTICA
    Product Code
    LKF
    PMA / PMN Number
    K142716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER EVENT ¿VCARE BROKE¿ WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE AND DEVICE EVALUATION. ONE 60-6085-201A RETURNED OPENED IN ORIGINAL PACKAGING. THE LOT NUMBER OF THE DEVICE - 202106291 WAS VERIFIED. A VISUAL INSPECTION CONFIRMED THE HANDLE OF THE V-CARE WAS SPINNING. THE HANDLE WAS TAKEN APART TO INSPECT THE TUBE, THE TUBE WAS BROKEN FROM THE MIDDLE WITH THE METAL TUBE SEPARATED AND THE LUMEN BETWEEN THE TWO PARTS OF THE BROKEN TUBE. 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 4 SIMILAR EVENTS INVOLVING 6 DEVICES FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 39 COMPLAINTS, REGARDING 47 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 THE FOLLOWING: 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. THIS ISSUE WILL CONTINUE TO BE MONITORED 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 (5103556) RECEIVED ON (B)(6) 2021. 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. THE REPORT STATES THAT ON (B)(6) 2021 THE ¿HANDLE OF VCARE BROKE (INTERNALLY WITHIN THE HANDLE) THE DEVICE WAS NO LONGER ABLE TO MANIPULATE THE UTERUS.¿ THERE WAS NO PATIENT IMPACT OR INJURY REPORTED. AFTER FURTHER ASSESSMENT IT WAS FOUND, THE PROCEDURE WAS ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, AND REMOVAL OF IUD. THE PROCEDURE WAS COMPLETED AND ONLY A FEW MINUTES DELAY WHILE THE UTERINE MANIPULATOR WAS EXCHANGED. THERE WAS NO IMMEDIATE INJURY NOTED TO THE PATIENT. A POST-OP OFFICE VISIT ON (B)(6) 2021 FOUND THE 52 YEAR OLD, FEMALE PATIENT WEIGHING 151 POUNDS RECOVERING APPROPRIATELY FROM SURGERY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    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

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (5103556) RECEIVED ON 13SEP21. 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. THE REPORT STATES THAT ON (B)(6) 2021 THE ¿HANDLE OF VCARE BROKE (INTERNALLY WITHIN THE HANDLE) THE DEVICE WAS NO LONGER ABLE TO MANIPULATE THE UTERUS.¿ THERE WAS NO PATIENT IMPACT OR INJURY REPORTED. AFTER FURTHER ASSESSMENT IT WAS FOUND, THE PROCEDURE WAS ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, AND REMOVAL OF IUD. THE PROCEDURE WAS COMPLETED AND ONLY A FEW MINUTES DELAY WHILE THE UTERINE MANIPULATOR WAS EXCHANGED. THERE WAS NO IMMEDIATE INJURY NOTED TO THE PATIENT. A POST-OP OFFICE VISIT ON (B)(6) 2021 FOUND THE (B)(6) YEAR OLD, FEMALE PATIENT WEIGHING (B)(6) RECOVERING APPROPRIATELY FROM SURGERY. 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
    1409923 VCARE 200A - MEDIUM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED UTICA 202106291

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR