BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 4008997 · Received July 9, 2014

    Report

    Report Number
    8010047-2014-00402
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC HAVE NOT RECEIVED THE SUBJECT PRODUCTS FOR EVALUATION YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT A PROCEDURE, THE SHEATH WAS KINKED. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401307 SINGLE USE ASPIRATION NEEDLE ASPIRATION NEEDLE FZG OLYMPUS MEDICAL SYSTEMS CORPORATION BA-201SX-4022

    Patients

    Seq Age Sex Outcome Treatment
    1