BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 4268939 · Received October 10, 2014

    Report

    Report Number
    8010047-2014-00578
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCTS WERE NOT RETURNED FOR EVAL SINCE THE USER FACILITY DISCARDED THEM. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. AS THE CHECKING OF THE MFG RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. 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." 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 DURING UNSPECIFIED PROCEDURE THE NEEDLE COULD NOT PROJECT OUT FROM THE SHEATH. THE DOCTOR USED 2 DEVICES FROM THE SAME PACK BUT ALSO FAILED IN SAME WAY. 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
    638165 SINGLE USE INJECTOR INJECTION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-400U-0425 47K

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) (MDR# 8010047-2014-00576/00577)