BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3973260 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00326
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 23, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCTS WAS RETURNED FOR OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE NEEDLE TUBE CAME AWAY FROM THE CONNECTION. THERE WAS NO ABNORMALITY OF THE OUTER DIAMETER OF THE CONNECTION PART. HOWEVER, THE INVESTIGATION CONFIRMED THAT TWO BENTS WERE DETECTED IN THE INSERTION TUBE. THUS, OMSC CONSIDERS THAT THE INSERTION TUBE WAS DEFORMED BY USER HANDLING. THAT CAUSED THE SEPARATION OF THE NEEDLE TUBE AND FAILURE OF NEEDLE OPERATION. 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 COLONOSCOPY, THE NEEDLE COULD NOT BE RETRACTED INTO THE TUBE. THE DOCTOR PULLED THE DEVICE IN THE ENDOSCOPE AND WITHDREW IT WITH ENDOSCOPE TOGETHER FROM THE PT. THERE WAS NO REPORT OF PT INJURY REGARDING THIS EVENT. HOWEVER, A PERFORATION OF THE CHANNEL OF THE ENDOSCOPE WAS FOUND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331395 SINGLE USE INJECTOR INJECTION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-200U-0425

    Patients

    Seq Age Sex Outcome Treatment
    1