BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 19911883 · Received August 5, 2024

    Report

    Report Number
    9614641-2024-01577
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 24, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170389917
    PMA / PMN Number
    K050503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (G2). THE SUBJECT DEVICE WAS MANUFACTURED ON AUGUST, 2023 BASED ON THE PROVIDED 3 DIGIT LOT INFORMATION. HOWEVER, THE EXACT MANUFACTURE DATE IS UNKNOWN. 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, IT IS LIKELY THAT THE REPORTED EVENT OCCURRED DUE TO THE SHEATH WAS PROTRUDED WHEN THE ANGLE OF THE ENDOSCOPE WAS TIGHT (UPMAX STATE), AND THE SHEATH CAME INTO CONTACT WITH THE INTERNAL PARTS OF THE ENDOSCOPE (METAL PIPE). FURTHERMORE, THE SHEATH IS THOUGHT TO HAVE BEEN SHAVED DUE TO INCREASED FRICTIONAL RESISTANCE CAUSED BY CONTACT BETWEEN THE SHEATH AND INTERNAL PARTS OF THE ENDOSCOPE (METAL PIPES) WHEN THE ENDOSCOPE ANGLE IS TIGHT (UPMAX STATE). HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED, AND THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "TAKE THE INSTRUMENT OUT OF THE TRAY BY HOLDING THE SHEATH NOT TO MAKE THE SHEATH POP OUT OF THE TRAY. OTHERWISE, THE INSERTION PORTION OF THE INSTRUMENT MIGHT BE BROKEN. ALSO, IF THE INSERTION PORTION POPS OUT OF THE TRAY BY ELASTICITY, DOCTORS OR PATIENTS MIGHT BE INJURED BY THE DISTAL END OF NEEDLE TUBE, SHEATH, AND STYLET." "DO NOT INSERT THIS INSTRUMENT WHEN THE ENDOSCOPE IS ANGULATED. THIS COULD DAMAGE THE ENDOSCOPE AND/OR THIS INSTRUMENT." "TURN THE UP/DOWN ANGULATION CONTROL LEVER TO THE NEUTRAL POSITION TO STRAIGHTEN THE ENDOSCOPE BEFORE THE INSERTION OF THIS INSTRUMENT INTO THE ENDOSCOPE. OTHERWISE, THIS COULD DAMAGE THE ENDOSCOPE AND/OR THIS INSTRUMENT." "IF YOU FEEL EXCESSIVE RESISTANCE WHILE OPERATING THE NEEDLE, DO NOT PUSH THE NEEDLE SLIDER FORCIBLY. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC BRONCHIAL ULTRASOUND, THERE WERE ISSUES WITH THE NEEDLE THROUGHOUT THE ENTIRE PROCEDURE. THE CUSTOMER ATTEMPTED TO DEPLOY THE NEEDLE SEVERAL TIMES, AND DOING SO, IT SHREDDED THE TIP OF THE SHEATH. THE PROCEDURE WENT OVER AN EXTRA HOUR OR SO DUE TO THE REPEATED SHREDDING OF THE SHEATHS OR THE EXTENSION OF THE COILS. ALSO, RECALIBRATING 3 EXTRA NEEDLES AS WELL. ANESTHESIA ALSO HAD TO BE EXTENDED BECAUSE OF THIS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE MALFUNCTION DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252634 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-201SX-4021 38V 04953170389917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other