BEUDAMED
    FDA Adverse Event Death Summary report: N

    VCARE, LARGE (37MM) CUP

    MDR report key: 7051269 · Received November 21, 2017

    Report

    Report Number
    1320894-2017-00260
    Event Type
    Death
    Date Received
    November 21, 2017
    Date of Event
    December 30, 2016
    Report Date
    November 21, 2017
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    PMA / PMN Number
    K071907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, ANY DEVICE ISSUE, LOT AND CATALOG NUMBER CANNOT BE VERIFIED. A REVIEW OF THE MANUFACTURING DOCUMENTS IS UNABLE TO BE COMPLETED DUE TO NO EXISTING RECORDS FOR THE REPORTED LOT NUMBER. A HISTORICAL REVIEW OF COMPLAINT DATA REVEALED THIS INCIDENT TO BE THE ONLY COMPLAINT IN THE PAST TWO YEARS FOR THIS DEVICE AND FAILURE MODE COMBINATION. IN THE SAME TIMEFRAME, (B)(4) UNITS HAVE BEEN SOLD WORLDWIDE, MAKING THE RATE OF OCCURRENCE OF THIS FAILURE (B)(4) PERCENT. THE CLINICAL DATA REPORT FOR THIS DEVICE STATES THAT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER, UNDESIRABLE SIDE EFFECTS DURING THE USE OF CONMED VCARE, UNDER NORMAL CONDITIONS OF USE, ARE ACCEPTABLE WHEN WEIGHTED AGAINST THE BENEFITS TO PATIENTS. FOR THE REPORTED INCIDENT, THE VCARE DEVICE WAS NOT USED AS INTENDED NOR UNDER NORMAL CONDITIONS OF USE. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING WARNINGS. DO NOT INJECT DYES/MARKING FLUIDS RAPIDLY AS HIGH INTRAUTERINE PRESSURE CAN DEVELOP. INJECTION OF SUCH FLUIDS CAN RESULT IN EXPULSION OF THE DEVICE FROM THE UTERUS, SPASM OF THE FALLOPIAN TUBES OR VASCULAR EXTRAVASATION. USE SLOW AND STEADY PRESSURE FOR INJECTION OF ANY APPROPRIATE DYE OR MARKER FLUID. DO NOT ATTACH OTHER DEVICES OR LINES OTHER THAT THE SYRINGE TO INJECT CONTRAST MEDIUM TO THE INJECTOR PORT. AS DEFINED IN THE (B)(6) MEDICAL LITERATURE, "THE (B)(6) SIDE-KICK UTERINE MANIPULATOR HOLDER IS INTENDED TO ASSIST THE SURGICAL STAFF IN MOUNTING, POSITIONING AND HOLDING A UTERINE MANIPULATOR DURING GYNECOLOGICAL LAPAROSCOPIC SURGICAL PROCEDURES." IT WARNS, "DO NOT ATTACH A GAS LINE TO A UTERINE MANIPULATOR, EXTREME DANGER." ALSO, "TO AVOID CONFUSION, MAKE THESE CONNECTIONS [GAS LINE CONNECTIONS] PRIOR TO INSERTING THE MANIPULATOR INTO THE PATIENT." BASED ON THE INFORMATION PROVIDED, THE POTENTIAL CAUSE OF THIS ISSUE IS USER RELATED. DUE TO THE SEVERITY OF THIS REPORTED INCIDENT, AN INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    CONMED BECAME AWARE OF AN EVENT INVOLVING A VCARE AND A (B)(6) SIDE KICK THROUGH A (B)(6) REPORT FILED UNDER (B)(6) MEDICAL. DURING A ROBOTIC HYSTERECTOMY, THE PATIENT RECEIVED AN AIR EMBOLI TO THE HEART DUE TO THE NITROGEN GAS BEING CONNECTED TO THE VCARE DYE INJECTION PORT. WHEN THIS WAS NOTICED THE NITROGEN GAS WAS TURNED OFF. DESPITE HEROIC MEASURES TO RESUSCITATE THE PATIENT, THE PATIENT PASSED AWAY. THIS REPORTED IS BEING RAISED BASED ON A PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828568 VCARE, LARGE (37MM) CUP VCARE LKF CONMED CORPORATION 201303091

    Patients

    Seq Age Sex Outcome Treatment
    1 Death