BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 16210361 · Received January 19, 2023

    Report

    Report Number
    9614641-2023-00091
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    March 12, 2022
    Report Date
    January 19, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170380440
    PMA / PMN Number
    K151738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE REPORTED MODEL 19G OLYMPUS EZ SHOT 3 FNA NEEDLE IS NOT A VALID NUMBER, OLYMPUS SELECTED NA-U200H-8019S AS A REPRESENTATIVE PRODUCT. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER MDR REPORT NUMBER 2429304 - 2023 ¿ 00009.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT CORRELATES WITH HISTOLOGICAL HEPATIC FIBROSIS." BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND IS A NOVEL DIAGNOSTIC APPROACH TO CHRONIC LIVER DISEASES (CLDS), AND EUS-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT (EUS-PPG) IS AN IMPORTANT EXPANSION WITH A WELL-DEVELOPED TECHNIQUE. HOWEVER, THE CLINICAL VALUE AND APPLICABILITY OF EUS-PPG MEASUREMENT IN PREDICTING HISTOLOGICALLY ADVANCED HEPATIC FIBROSIS REMAIN UNKNOWN. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY ON PATIENTS WITH VARIOUS CLDS UNDERGOING EUS-PPG AND EUS-GUIDED LIVER BIOPSY (EUS-BX) TO ASSESS IF EUS-PPG MEASUREMENTS CORRELATE WITH HISTOLOGICAL FIBROSIS STAGE AND VARIOUS SURROGATE MARKERS FOR SEVERITY OF CLDS AND ITS SAFETY. CASES WITH EUS-PPG WERE IDENTIFIED AT THE UNIVERSITY OF CALIFORNIA IRVINE, A TERTIARY ENDOSCOPY CENTER, BETWEEN JANUARY 2014 AND MARCH 2020. RESULTS: IN 64 PATIENTS, THE MEAN AGE WAS 57.5; 40 (62.5%), MALES; MEAN CHILD-TURCOTTE-PUGH (CTP) AND MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORES, 5.9 AND 10.4, RESPECTIVELY. THE PROCEDURE SUCCESS RATE WAS 100%. TWENTY-NINE (45.3%) HAD EUS-PPG=5 MMHG THAT WAS ASSOCIATED WITH CLINICAL CIRRHOSIS (P<0.0001), CLINICAL PORTAL HYPERTENSION (P=0.002), HEPATIC DECOMPENSATION (P=0.013), MELD-NA>10 (P=0.036), PLTS=120×109/L (P=0.001), INR=1.05 (P=0.007), PRESENCE OF EV, GV, OR PHG (P<0.0001), BIOPSY-PROVEN FIBROSIS STAGE=3 (P=0.002), APRI>2 (P=0.001), AND FIB-4>3.25 (P=0.001). MULTIVARIABLE ANALYSIS CONFIRMED THAT EUS-PPG=5 MMHG WAS SIGNIFICANTLY ASSOCIATED WITH LIVER BIOPSY-PROVEN FIBROSIS STAGE= 3 (LR 27.0, 95% CI=1.653¿360.597, P=0.004), INDEPENDENT OF C-CIRRHOSIS, C-PHTN, THROMBOCYTOPENIA, SPLENOMEGALY, AND APRI SCORE>2, AND FIB-4 SCORE>3.25. THERE WERE NO SERIOUS COMPLICATIONS RELATED TO EUS-PPG PROCEDURES. CONCLUSIONS: EUS-PPG MEASUREMENTS PROVIDE EXCELLENT CORRELATION WITH HISTOLOGICAL HEPATIC FIBROSIS STAGE AND VARIOUS CLINICAL, LABORATORY, ENDOSCOPIC AND IMAGING VARIABLES INDICATIVE OF ADVANCED LIVER DISEASE WITHOUT SERIOUS ADVERSE EVENTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: CIRRHOSIS THROMBOCYTOPENIA. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6). THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406819 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8019S UNKNOWN (LITERATURE) 04953170380440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other