BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3961377 · Received May 30, 2014

    Report

    Report Number
    8010047-2014-00290
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 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 DEVICES WERE DISCARDED BY THE USER FACILITY. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC ASSUMES THAT INSERTION PORTION OF THE DEVICE WAS DEFORMED AND IT CAUSED THE FAILURE TO EXTEND THE NEEDLE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2014-00289.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP. (OMSC) WAS INFORMED THAT DURING A COLONOSCOPY, THE FACILITY PRIMED 3 NEEDLES AND CHECKED THEM AND THEY WORKED FINE. HOWEVER, ONCE INSIDE THE SCOPE, THEY WOULD NOT DEPLOY. NEEDLES APPEARED BENT AND STUCK IN THE SHEATH. THE COLONOSCOPE WASN'T OVERLY KINKED INSIDE THE PT. TWO NEEDLES FAILED AND THE DOCTOR COMPLETED THE PROCEDURE WITH THIRD ONE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318044 SINGLE USE INJECTOR INJECTION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-400U-0523 42K

    Patients

    Seq Age Sex Outcome Treatment
    1