BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 18055199 · Received November 2, 2023

    Report

    Report Number
    3002808148-2023-12154
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    August 4, 2023
    Report Date
    February 20, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356322
    PMA / PMN Number
    K011314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00343 THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION COULD BE PROVIDED. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLICATION OR IF ADDITIONAL INFORMATION IS RECEIVED. THE LITERATURE DESCRIBED ULTRASONIC GASTROVIDEOSCOPE- MODEL -GF-UC140P-AL5, SN -UNK (FOR DEVICE GF-UC180P-AL5 IN THE LITERATURE) IS ADDED AS A REPRESENTATIVE PRODUCT WITH THE SAME PROCODE.

    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 INCLUDED A CORRECTION TO B3 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PERFORMANCE OF ENDOSCOPIC ULTRASOUND-GUIDED VERSUS PERCUTANEOUS LIVER BIOPSY IN DIAGNOSING STAGE 3¿4 FIBROSIS" LITERATURE SUMMARY: THIS RETROSCPECTIVE STUDY AIMED TO EVALUATE IF EUS-BX, COMPARED TO P-BX, CAN EFFECTIVELY AND SAFELY OBTAIN ADEQUATE SPECIMEN AND ACCURATELY PREDICT HEPATIC FIBROSIS. THIS IS A SINGLE CENTER, RETROSPECTIVE CHART REVIEW AMONG PATIENTS WITH LIVER DISEASES AT A TERTIARY ENDOSCOPY CENTER FROM (B)(6) 2011 TO (B)(6) 2020. WE ASSESSED THE EUS-BX VERSUS 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). 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. CONCLUSIONS: EUS-BX CAN SAFELY PERFORMED AND ACCURATELY PREDICT LIVER FIBROSIS STAGE AS THE STANDARD P-BX WITHOUT BEING INFLUENCED BY PROCEDURE-RELATED FACTORS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: 2 PATIENTS ON EUS-BX VERSUS ZERO PERCUTANEOUS LIVER BIOPSY COMPLICATION LED TO AN ER VISIT 2 PATIENTS ON EUS-BX VERSUS ZERO PERCUTANEOUS LIVER BIOPSY COMPLICATION LED TO A HOSPITALIZATION FOR OBSERVATION. 1 PATIENT WHO UNDERWENT EUS-BX HAD THROMBOCYTOPENIA WITH PLATELET COUNT OF 101 × 10**9/L,(STAGE 3 FIBROSIS, WHO CALLED, WAS ADVISED TO PRESENT TO THE ER, AND WAS EVALUATED AND SENT HOME WITHOUT HOSPITALIZATION. 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 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
    2009888 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UC140P-AL5 04953170356322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization SINGLE USE ASPIRATION NEEDLE NA-U200H-8019, SN-UNK.| ULTRASONIC GASTROVIDEOSCOPE, GF-UC140P-AL5, SN-UNK.