BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 3961084 · Received May 26, 2014

    Report

    Report Number
    8010047-2014-00297
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC HAVE NOT RECEIVED THE SUBJECT PRODUCTS FOR EVAL YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADD'L AND SIGNIFICANT INFO 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 SYSTEM CORP (OMSC) WAS INFORMED THAT DURING ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION (EBUS), THE SHEATH WAS KINKED TOWARDS THE END ABOUT 45 MINUTES INTO A PROCEDURE. THE KINK WAS SO SEVERE THAT IT CAUSED A SPLIT, WHICH NEEDLE COULD POTENTIALLY PROTRUDE THROUGH. THE DOCTOR COMPLETED THE PROCEDURE WITH A SIMILAR DEVICE. OMSC WAS INFORMED THAT THE DOCTOR WAS NOT CONCERNED THAT PT SAFETY COULD BE COMPROMISED, BUT THE NEEDLE MIGHT CAUSE DAMAGE TO THE ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310086 SINGLE USE ASPIRATION NEEDLE ASPIRATION NEEDLE GAA OLYMPUS MEDICAL SYSTEMS CORPORATION NA-201SX-4022

    Patients

    Seq Age Sex Outcome Treatment
    1