BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U401SX

    MDR report key: 17452253 · Received August 3, 2023

    Report

    Report Number
    9614641-2023-01080
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 26, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170388248
    PMA / PMN Number
    K160098
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00251. TO DATE, THIS SUBJECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE THE CORRECT DEVICE LOT NUMBER (K114558) IN D4.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, SINCE THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION, THE REPORTED ISSUE (TIP SHEATH FELL OFF /PROLONGED PROCEDURE ¿ UNSPECIFIED DELAY TIME) COULD NOT BE CONFIRMED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿DO NOT APPLY EXCESSIVE BENDING, PULLING OR PRESSURE TO THIS PRODUCT. IT MAY LEAD TO EQUIPMENT DAMAGE OR FUNCTIONAL DETERIORATION. DO NOT ROUND THE INSERTION TUBE SMALLER THAN 15 CM IN DIAMETER. THE ASPIRATION BIOPSY NEEDLE MAY BREAK. DO NOT INSERT THE ASPIRATION BIOPSY NEEDLE WHILE THE ENDOSCOPE IS ANGLED. DAMAGE TO THE ENDOSCOPE OR ASPIRATION BIOPSY NEEDLE MAY RESULT. RETURN THE ENDOSCOPE'S UP/DOWN ANGLE LEVER TO NEUTRAL BEFORE INSERTING THE ASPIRATION NEEDLE INTO THE ENDOSCOPE. INSERTION WITH THE ANGLE FIXED MAY DAMAGE THE ENDOSCOPE OR ASPIRATION NEEDLE. WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, THE DISTAL END OF THE NEEDLE TUBE MAY BE BENT. WHEN PIERCING THE TARGET, CONFIRM THE DISTAL END OF THE SHEATH AND NEEDLE TUBE IN THE ENDOSCOPIC FIELD OF VIEW AND/OR ULTRASOUND IMAGE WHILE CONSIDERING SUCH BENDING. OTHERWISE, PATIENT INJURIES SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE MAY OCCUR. DO NOT TRY TO STRAIGHTEN A BENT OR DEFORMED NEEDLE WITH YOUR HANDS BECAUSE THE NEEDLE MAY BREAK. USE A SPARE NEEDLE INSTEAD.¿ THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO B5 AND D9 FROM THE INITIAL MEDWATCH. ALSO, ADDITIONAL INFORMATION HAS BEEN ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS EVALUATED BY OLYMPUS, THE FOLLOWING WAS OBSERVED: BUCKLING WAS NOTED AT MULTIPLE LOCATION ON THE INSERT. ALSO, THE GREEN SHEATH WAS SCRAPED OFF. BASED ON THE RESULTS OF THE INVESTIGATION, THE SHEATH TIP BREAKAGE WAS LIKELY CAUSED BY THE SHEATH BEING PROTRUDED AT A SEVERE ANGLE WHICH RESULTED IN THE SHEATH CONTACTING THE INTERNAL PARTS OF THE ENDOSCOPE (METAL PIPE) CAUSING INCREASED FRICTIONAL RESISTANCE. THIS FAILURE RESULTED IN AN UNSPECIFIED PROLONGATION OF THE PROCEDURE. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO D9, H3, AND H6 FROM THE PREVIOUS SUBMISSIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A DIAGNOSTIC PROCEDURE, SPECIMEN RETRIEVAL, THE CATHETER SHEATH FELL APART, SHREDDED OR PIECES CAME OFF. NOTHING WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS PROLONGED FOR SIXTY-FIVE MINUTES TO OPEN A NEW DEVICE AND COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    CORRECTION: THE INCIDENT OCCURRED DURING A FINE NEEDLE ASPIRATION (FNA) OF THE PATIENT¿S SUBCARINAL LYMPH NODE AND LEFT HILAR MASS. THE TOTAL DURATION OF THE PROCEDURE WAS 65 MINUTES. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED DUE TO THE NEED TO OPEN ANOTHER NEEDLE. HOWEVER, THE EXACT TIME IT TOOK TO OPEN THE NEW DEVICE WAS UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337845 SINGLE USE ASPIRATION NEEDLE NA-U401SX SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U401SX-4021 K114558 04953170388248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention