BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3961379 · Received May 30, 2014

    Report

    Report Number
    8010047-2014-00293
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES WERE NOT RETURNED TO OMSC FOR INVESTIGATION. 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. THE INSTRUCTIONS 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 AAS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2014-00291, 292, 294.

    Description of Event or Problem · 1

    OLYMPUS MED SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE 4 NEEDLES DID NOT WORK CORRECTLY. THEY WORKED BEFORE BEING INSERTED INTO THE ENDOSCOPE BUT ONCE INSERTED THEY FAILED TO OPEN AND CLOSE. ONE OF THE NEEDLES COULD NOT BE RETRACTED INTO THE SHEATH AND IT CAUSED A PERFORATION OF THE CHANNEL OF THE ENDOSCOPE. 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
    318350 SINGLE USE INJECTOR INJECTION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-400U-0423 43K

    Patients

    Seq Age Sex Outcome Treatment
    1 PLEASE CROSS REFERENCE 8010047-2014-00291,292,294