BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STABILIZER ARM, HERCULES 3

    MDR report key: 6286900 · Received January 30, 2017

    Report

    Report Number
    3003502395-2017-00018
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 3, 2017
    Manufacturer
    ATRICURE INC.
    Product Code
    DWS
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICES WERE RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0371.A. THE COMPLAINT WAS CONFIRMED UPON RECEIPT OF THE DEVICE. THE CABLE HAS BROKEN AND STARTED TO FRAY. CABLES ARE SUSCEPTIBLE TO FAILURE IF THE DEVICE IS NOT MAINTAINED AND UTILIZED PER THE PRODUCT'S INSTRUCTIONS.

    Description of Event or Problem · 1

    STERILE PROCESSING ASSISTANT AT HOSPITAL STATED THAT TWO HERCULES RETRACTORS WERE BROKEN AND THAT THEY CANNOT BE USED IN SURGERY. IT WAS STATED THAT THE CABLE ON BOTH OF THE DEVICES WERE SEVERED AND FRAYED. IT LOOKS AS IF THEY COULD HAVE BEEN TIGHTENED UNTIL THE CABLE SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69639 UNIVERSAL STABILIZER ARM, HERCULES 3 HERCULES 3 UNIVERSAL STABILIZER ARM DWS ATRICURE INC. HERCULES 72413 , 72458

    Patients

    Seq Age Sex Outcome Treatment
    1