BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 18691141 · Received February 12, 2024

    Report

    Report Number
    9614641-2024-00348
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    October 20, 2023
    Report Date
    February 19, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170380488
    PMA / PMN Number
    K180449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "EZ SHOT 2/EZ SHOT 3 PLUS",OLYMPUS SELECTED "NA-U200H-8022" AS A REPRESENTATIVE PRODUCT. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "SAFETY AND DIAGNOSTIC YIELD OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY FOR HYPERVASCULAR PANCREATIC LESIONS."     ¿LITERATURE SUMMARY¿ THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY AND DIAGNOSTIC YIELD OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY (EUS-FNB) FOR HYPERVASCULAR PANCREATIC SOLID LESIONS. A TOTAL OF 301 PATIENTS WERE INCLUDED. THE SENSITIVITY, SPECIFICITY, AND ACCURACY RATES OF EUS-FNB FOR HYPERVASCULAR LESIONS WERE 94.7%, 100%, AND 96.2%, AND THOSE FOR HYPOVASCULAR LESIONS WERE 80.0%, 100%, AND 84.6%, RESPECTIVELY. THERE WAS NO DIFFERENCE IN DIAGNOSTIC PERFORMANCE BETWEEN HYPERVASCULAR AND HYPOVASCULAR LESIONS.     ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ 1) EVENT #1 -BLEEDING - 3 PATIENTS 2) EVENT #2 PANCREATITIS - 3 PATIENTS 3) EVENT #3 INFECTION - 1 PATIENT 4) EVENT #4 PAIN - 1 PATIENT   THE REPORT IS LINKED TO THE RELATED PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278791 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8022 04953170380488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other GASTROVIDEOSCOPE, GF-UCT260