BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STABILIZER ARM, HERCULES 3

    MDR report key: 7054307 · Received November 22, 2017

    Report

    Report Number
    3011706110-2017-00100
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    September 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    DWS
    PMA / PMN Number
    D233474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED ON 10/26/2017. UPON EVALUATION, THE COMPLAINT WAS CONFIRMED. IT WAS IDENTIFIED THAT THE TWO LOCK PLATES WERE MISSING, MAKING THE DEVICE LOCKING MECHANISM INOPERABLE. THIS DEFICIENCY WAS FOUND POST-STERILIZATION. FURTHER INVESTIGATION IS REQUIRED FOR THIS DEVICE MALFUNCTION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ON (B)(4) 2017, IT WAS REPORTED THAT THE HERCULES 3 UNIVERSAL STABILIZER ARM WAS BROKEN. PER THE CUSTOMER, THE DEVICE WAS RECEIVED BROKEN UPON RETURN FROM STERILE PROCESSING. DUE TO THE NATURE OF THE DEVICE MALFUNCTION, IT COULD NOT BE USED FOR ANY PROCEDURES. THE DEVICE IS UNDER WARRANTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832422 UNIVERSAL STABILIZER ARM, HERCULES 3 UNIVERSAL STABILIZER ARM, HERCULES 3 DWS ATRICURE, INC. 001-401-161 71084

    Patients

    Seq Age Sex Outcome Treatment
    1