BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZISHOT ASPIRATION NEEDLE

    MDR report key: 7428410 · Received April 12, 2018

    Report

    Report Number
    MW5076460
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 22, 2018
    Report Date
    April 5, 2018
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    KTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE IN PT OBTAINING SAMPLE, UNABLE TO REMOVE STYLET. DELAYED SAMPLE PROCUREMENT. ENDOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267152 VIZISHOT ASPIRATION NEEDLE VIZISHOT ASPIRATION NEEDLE KTI OLYMPUS SURGICAL TECHNOLOGIES AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR