BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 14839133 · Received June 28, 2022

    Report

    Report Number
    8010047-2022-10889
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 27, 2022
    Report Date
    July 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    UDI-DI
    04953170422621
    PMA / PMN Number
    K902736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). DEVICE EVALUATION AND INSPECTION, NOTED NEEDLE CAN BE RETRACTED HOWEVER IT BECOME STUCK AND UNABLE TO EXTEND. STILL POSSIBLE TO INJECT FLUID (NO BLOCKAGE). FLUID REMAINED INSIDE. INTERNALLY SOILED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: D4, H6, H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE WAS DUE TO COMPRESSIVE BUCKLING OF THE NEEDLE TUBE. THIS LIKELY OCCURRED WHEN THE NEEDLE WAS EXTENDED BECAUSE OF THE GREAT FRICTION BETWEEN THE OUTER TUBE AND THE NEEDLE. IT WAS LIKELY THAT THE FRICTION BETWEEN THE OUTER TUBE AND THE NEEDLE INCREASED BY THE FOLLOWING FACTORS: ·THE NEEDLE EXTENDED/RETRACTED WHILE THE TUBE WAS COILED IN INSPECTION OF OPERATION. ·THE SLIDER WAS ABRUPTLY PUSHED. ·THE KINK OF THE TUBE. ·ANGLE OF THE DISTAL END OF THE ENDOSCOPE THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATES: ·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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, BEFORE THE PROCEDURE THE NURSE INSPECTS THE INJECTOR AND USE THE ADRENALINE SOLUTION TO TEST THE INJECTION AND THERE WAS NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE HAS ALSO TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, BUT THE SAME ISSUE TRANSPIRED. THEREFORE, A SECOND INJECTOR WAS OPENED AND USED TO CONTINUE THE PROCEDURE. THE INTENDED PROCEDURE (BLEEDING CASE GASTRIC ULCER) WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE . THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS FOR THE FIRST INJECTION NEEDLE UNIT LOT OZK. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (SECOND INJECTION NEEDLE UNIT) LOT 16K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044153 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-401L-0423 0ZK 04953170422621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SCOPE.