BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP IMPLANT DEVICE

    MDR report key: 11831415 · Received May 14, 2021

    Report

    Report Number
    MW5101366
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ATRICURE, INC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE ATRICLIP IMPLANT DEVICE REFERENCE # ACH245 (ATRICURE) WILL OPEN CLIP BUT NOT ACTIVATE IMPLANT CLIP. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725687 ATRICLIP IMPLANT DEVICE CLIP, IMPLANTABLE FZP ATRICURE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1