BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 10287738 · Received July 17, 2020

    Report

    Report Number
    8010047-2020-04507
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Report Date
    July 17, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    UDI-DI
    04953170382352
    PMA / PMN Number
    K902736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE NEEDLE COULD NOT BE EXTENDED FROM THE OUTER TUBE. INJECTION COULD NOT BE PERFORMED WHILE THE SLIDER WAS PUSHED, BUT INJECTION COULD BE PERFORMED WHILE THE SLIDER WAS PULLED. THE OUTER TUBE WAS BUCKLED AT 430 MM, 850 MM, 1095MM, 1160MM AND 1180MM FROM THE DISTAL END. THE NEEDLE TUBE WAS COMPRESSIVE BUCKLED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE FRICTIONAL RESISTANCE BETWEEN THE OUTER TUBE AND THE NEEDLE TUBE INCREASED DUE TO THE BENDING OF THE TUBE OR PUSHING THE SLIDER ABRUPTLY, AND THEN THE NEEDLE TUBE WAS COMPRESSIVE BUCKLED WHEN THE NEEDLE WAS EXTENDED AND INJECTION COULD NOT BE PERFORMED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. STRAIGHTEN OUT THE INSTRUMENT BEFORE INSPECTING IT. THE INSTRUMENT CAN BE DAMAGED IF IT IS COILED WHILE THE HANDLE IS OPERATED. OPERATE THE SLIDER SLOWLY, OTHERWISE THE TUBE COULD BUCKLE. WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, RETRACT THE NEEDLE INTO THE SHEATH, HOLD THE INSTRUMENT CLOSE TO THE BIOPSY VALVE, AND KEEP IT AS STRAIGHT AS POSSIBLE RELATIVE TO THE BIOPSY VALVE. OTHERWISE, THE INSTRUMENT COULD BE DAMAGED. INSERT THE INSTRUMENT SLOWLY. ABRUPT INSERTION COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. STOP USING THE INSTRUMENT IF THE INSERTION PORTION BENDS EXCESSIVELY DURING USE. THIS COULD RESULT IN MALFUNCTION, SUCH AS FAILING TO EXTEND THE NEEDLE OR INJECT A FLUID.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE NEEDLE COULD NOT BE EXTENDED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 3, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE SUBJECT DEVICE COULD NOT PERFORM THE INJECTION. THIS IS THE REPORT REGARDING THE FAILURE OF INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755053 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-401L-0523 K9820 04953170382352

    Patients

    Seq Age Sex Outcome Treatment
    1