BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 18055085 · Received November 2, 2023

    Report

    Report Number
    2429304-2023-00341
    Event Type
    Injury
    Date Received
    November 2, 2023
    Report Date
    November 27, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356322
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 RETROSPECTIVE 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 FEBRUARY 2011 TO MARCH 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.

    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
    156702 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UC140P-AL5 04953170356322

    Patients

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