BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STABILIZER ARM, HERCULES 3

    MDR report key: 6059147 · Received October 26, 2016

    Report

    Report Number
    3003502395-2016-00144
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF DEVICE EVALUATION, MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON DEVICE EVALUATION, THE COMPLAINT WAS CONFIRMED. THE MOUNTING AND LOCKING MECHANISM WAS FUNCTIONAL ALTHOUGH THE CABLE WAS FOUND TO BE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VALVE REPAIR PROCEDURE, THE DEVICE BROKE INTO PIECES. NO PIECES FELL INTO THE PATIENT'S BODY CAVITY. THIS RESULTED IN A SLIGHT DELAY OF TEN MINUTES TO OPEN ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708357 UNIVERSAL STABILIZER ARM, HERCULES 3 UNIVERSAL STABILIZER ARM, HERCULES 3 DWS ATRICURE, INC. 001-401-161

    Patients

    Seq Age Sex Outcome Treatment
    1