BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 3964467 · Received May 23, 2014

    Report

    Report Number
    8010047-2014-00286
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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 PRODUCT WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE TUBE BROKE AT THE 18MM POSITION FROM THE DISTAL END AND THE NEEDLE COULD NOT BE RETRACTED INTO THE TUBE. THE DISTAL END OF THE BROKEN TUBE WAS STRETCHED AND PARTIALLY TURNED WHITE. AS THE RESULT OF CHECKING THE MFG RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. 100% INSPECTION IS PERFORMED ON THIS DEVICE AND IT IS NOT POSSIBILITY THAT THERE WAS AN ABNORMALITY OF THE TUBE FROM BEGINNING. SO, OMSC ASSUMES THAT USER HANDLING CAUSED THE BREAKAGE OF THE TUBE. THE DEVICE INSTRUCTION MANUAL HAS WARNS USERS THAT "DO NOT INSERT THE INSTRUMENT INTO THE ENDOSCOPE UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. IF YOU CANNOT SEE THE DISTAL END OF THE INSERTION PORTION IN THE ENDOSCOPIC FIELD OF VIEW, DO NOT USE THE INSTRUMENT. THIS COULD CAUSE PT INJURY, SUCH AS PERFORATION, BLEEDING OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT." THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) OF COLON, THE DOCTOR COULD PERFORM LOCAL INJECTION WITH SUBJECT DEVICE AT FIRST. HOWEVER, HE NOTICED THAT THE LENGTH OF THE TUBE SHORTENED ABOUT 1 CM AND THE NEEDLE COULD NOT BE RETRACTED INTO THE TUBE DURING PERFORMING SEVERAL INJECTIONS. THEN, HE WITHDREW THE SUBJECT DEVICE FROM THE ENDOSCOPE AND COMPLETED THE PROCEDURE BY USING ANOTHER DEVICE, IT'S NOT KNOWN WHERE AND WHEN THE TUBE SHORTENED. THERE WAS NO REPORT OF PT INJURY AND ENDOSCOPE DAMAGE REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307383 SINGLE USE INJECTOR INJECTION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NM-400U-0423 K4325

    Patients

    Seq Age Sex Outcome Treatment
    1