BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 12920029 · Received December 2, 2021

    Report

    Report Number
    8010047-2021-15432
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 8, 2021
    Report Date
    May 6, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170381911
    PMA / PMN Number
    K050503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. PER THE LEGAL MANUFACTURER, THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THE EVENT WAS DETERMINED TO BE REPORTABLE FOR A MALFUNCTION. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING THAT WAS ALREADY OPENED. VISUAL INSPECTION FOUND THE INSERTION PORTION OF THE ASPIRATION NEEDLE WAS KINKED AND BENT. THE INSERTION PORTION OF THE NEEDLE WAS BENT AT THE BOOT. THE DEVICE WAS RECEIVED WITH THE NEEDLE STICKING OUT OF THE DISTAL END. THE DISTAL END SIDE OF THE NEEDLE WAS CURVED AND NOT STRAIGHT. THE TIP OF THE NEEDLE WAS ALSO SLIGHTLY BENT. MOVEMENT FROM THE ASPIRATION NEEDLE WHEN MANIPULATING THE SLIDER HANDLE WAS ABNORMAL AND THE NEEDLE WOULD NOT EXTEND OR RETRACT. THE STYLET WIRE WAS NOT RETURNED WITH THE DEVICE. THE STOPPER AND SHEATH ADJUSTER BOTH FUNCTIONED AS INTENDED. THERE WAS SOME MINOR RESIDUAL BUILD UP AT THE DISTAL END OF THE INSERTION PORTION. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: H4, H6 AND H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN MORE THAN 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE NEEDLE BROKE DUE TO THE FOLLOWING MECHANISM: 1) A BENDING LOAD WAS APPLIED TO THE NEEDLE TUBE WHEN INSERTING THE ENDOSCOPE OR REMOVING IT FROM THE TRAY, AND THE NEEDLE TUBE BENT SIGNIFICANTLY. 2) A LOAD WAS APPLIED IN THE DIRECTION OF STRAIGHTENING THE BENT NEEDLE TUBE, CAUSING IT TO BREAK. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ·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 INJURY 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. ·WHEN REMOVING THE ASPIRATION BIOPSY NEEDLE FROM THE TRAY, HOLD THE SHEATH TO PREVENT IT FROM FLYING OFF THE TRAY. IF YOU REMOVE THE SHEATH WITHOUT HOLDING IT, THE INSERTION PART OF THE ASPIRATION BIOPSY NEEDLE MAY BE DAMAGED. ADDITIONALLY, DUE TO THE ELASTICITY OF THE INSERTION TUBE, THE ENTIRE INSERTION TUBE MAY JUMP, CAUSING INJURY TO THE OPERATOR OR PATIENT DUE TO THE TIP OF THE NEEDLE TUBE, SHEATH, OR STYLET. ·DO NOT APPLY EXCESSIVE BENDING, PULLING, OR PRESSURE TO THIS PRODUCT. FAILURE TO DO SO MAY RESULT IN EQUIPMENT DAMAGE OR REDUCED FUNCTIONALITY. ·DO NOT ROLL THE INSERTION PART SMALLER THAN 15CM IN DIAMETER. THE ASPIRATION BIOPSY NEEDLE MAY BE DAMAGED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION IS STILL PENDING. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED, NEEDLE BROKE IN THE MIDDLE OF THE GUIDE SHEATH AFTER TWO PUNCTURES. THE ISSUE FOUND DURING A DIAGNOSTIC LINEAR EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY) PROCEDURE. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE WITH SAME MODEL AND SAME LOT NUMBER (NA-201SX-4021 LOT OZV ). THE INTENDED PROCEDURE WAS COMPLETED WITH NO INJURY OR HARM TO THE PATIENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818789 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-201SX-4021 0ZV 04953170381911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown