BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHILLON SYSTEM

    MDR report key: 4180714 · Received October 15, 2014

    Report

    Report Number
    9615741-2014-00050
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON ATTEMPTED TO USE THE NEEDLE DRIVER TO INSERT THE NEEDLE INTO THE ACHILLON. AS SOON AS PRESSURE WAS APPLIED THE TUBULAR PORTION OF THE NEEDLE DRIVER BROKE OFF, LEAVING THE FLAT PORTION FOR USE. THE SURGERY FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653675 ACHILLON SYSTEM ACHILLON HCF NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1