BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3973277 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00323
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 20, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCTS WERE NOT RETURNED FOR EVAL YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THERE ARE POSSIBILITIES THAT THE INSERTION PORTION OF THE DEVICE WAS DEFORMED AND IT CAUSED THE FAILURE TO EXTEND THE NEEDLE. THE INSTRUCTION MANUAL WARNS USERS THAT "STRAIGHTEN OUT THE INSTRUMENT BEFORE INSPECTING IT. THE INSTRUMENT CAN BE DAMAGED IF IT IS COILED WHILE THE HANDLE IS OPERATED". A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REF: 8010047-2014-00321/00322/00324.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE, THE FACILITY CONFIRMED THAT THE NEEDLES WORKED CORRECTLY, BUT THEY DID NOT PROJECT OUT OF THE SHEATH WHEN THEY WERE INSERTED INTO THE ENDOSCOPE. THIS HAPPENED ON 4 OCCASIONS. THE DOCTOR COMPLETED THE PROCEDURE WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331543 SINGLE USE INJECTOR INJECTION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-400U-0425 42K

    Patients

    Seq Age Sex Outcome Treatment
    1