BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 18041381 · Received October 31, 2023

    Report

    Report Number
    9614641-2023-01641
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    August 4, 2023
    Report Date
    December 19, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170380402
    PMA / PMN Number
    K180449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. HTTPS://DOI.ORG/10.1007/S10620-023-08019-8. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00342. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    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 EVENT 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. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO E3 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING CREATED AS A CORRECTION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B5 AND D10. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS SUPPLEMENTAL REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304 - 2023 - 00341.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF ENDOSCOPIC ULTRASOUND-GUIDED VERSUS PERCUTANEOUS LIVER BIOPSY IN DIAGNOSING STAGE 3¿4 FIBROSIS" THIS IS A SINGLE CENTER, RETROSPECTIVE CHART REVIEW AMONG PATIENTS WITH LIVER DISEASES AT A TERTIARY ENDOSCOPY CENTER FROM FEBRUARY 2011 TO MARCH 2020. WE ASSESSED THE EUS-GUIDED BIOPSY (EUS-BX) VERSUS PERCUTANEOUS LIVER BIOPSY (P-BX) OUTCOMES BY SUCCESS RATE, PERFORMANCE, AND SAFETY PROFILE. THE PRIMARY OUTCOME WAS THE ASSOCIATION BETWEEN EUS-BX CLINICAL VARIABLES AND THE PRESENCE OF HISTOLOGIC LIVER FIBROSIS STAGE = 3. THE SECONDARY OUTCOMES WERE THE ASSOCIATIONS BETWEEN EUS-BX AND VARIABLES INDICATIVE OF FIBROSIS. RESULTS: FIFTY-NINE PATIENTS UNDERWENT EUS-BX; AND 59, P-BX. ALL EUS-BX PROCEDURES WERE SUCCESSFULLY COMPLETED. ALL 56/56 (100%) OF EUS-BX VS. 50/52 (96.2%) P-BX WERE CONSIDERED ADEQUATE SAMPLES. TISSUE LENGTHS WERE SIGNIFICANTLY LONGER IN THE EUS-BX COHORT (P < 0.0001) WITH A TREND TOWARDS A GREATER NUMBER OF PORTAL TRACTS. 46/56 (82.1%) CASES OF EUS-BX VS. 32/52 (61.5%) OF P-BX HAD > 10 PORTAL TRACTS; 21/56 (37.5%) CASES OF EUS-BX VS. 14/52 (26.9%) OF P-BX HAD > 15 PORTAL TRACTS. THERE WERE 6 (10.2%) EUS-BX VS. 1 (1.7%) P-BX RELATED COMPLICATION LEADING TO A PHONE CALL (P = 0.061). CONCLUSIONS: EUS-BX CAN SAFELY PERFORMED AND ACCURATELY PREDICT LIVER FIBROSIS STAGE AS THE STANDARD P-BX WITHOUT BEING INFLUENCED BY PROCEDURE-RELATED FACTORS. COMPLICATIONS: EIGHT PATIENTS WHO UNDERWENT EUS-BX AND ONE PATIENT WHO UNDERWENT P-BX HAD COMPLICATIONS. THERE WERE 6 (10.2%) EUS-BX VERSUS 1 (1.7%) P-BX RELATED COMPLICATION LEADING TO A POST-PROCEDURE PHONE CALL (P = 0.061). TWO (3.4%) EUS-BX VERSUS ZERO PERCUTANEOUS LIVER BIOPSY COMPLICATION LED TO AN ER VISIT (P = 0.496). TWO (3.4%) EUS-BX VERSUS ZERO PERCUTANEOUS LIVER BIOPSY COMPLICATION LED TO A HOSPITALIZATION FOR OBSERVATION, (P = 0.496). ONE PATIENT WHO UNDERWENT EUS-BX HAD THROMBOCYTOPENIA WITH PLATELET COUNT OF 101 × 109/L, STAGE 3 FIBROSIS, WHO CALLED, WAS ADVISED TO PRESENT TO THE ER, AND WAS EVALUATED AND SENT HOME WITHOUT HOSPITALIZATION. THE OTHER 7 PATIENTS HAD NO COAGULOPATHY OR THROMBOCYTOPENIA. NONE OF THEM WERE ON ANTICOAGULATION OR ANTIPLATELET AGENTS. THIS LITERATURE ARTICLE REQUIRES 1 REPORT. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    THIS LITERATURE ARTICLE REQUIRES 3 REPORTS: 1) (B)(6) -ULTRASONIC GASTROVIDEOSCOPE, MODEL- GF-UC140P-AL5, SN-UNK. 2) (B)(6) -- ULTRASONIC GASTROVIDEOSCOPE- MODEL -GF-UC140P-AL5- SN -UNK (FOR GF-UC180P-AL5 IN THE LITERATURE AS A REPRESENTATIVE PRODUCT WITH THE SAME PROCODE). 3) (B)(6) - SINGLE USE ASPIRATION NEEDLE NA-U200H NA-U200H-8019, SN-UNK. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150592 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8019 04953170380402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization ULTRASONIC GASTROVIDEOSCOPE GF-UC140P-AL5, SN-UNK