BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 14016324 · Received April 5, 2022

    Report

    Report Number
    8010047-2022-05715
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    September 4, 2020
    Report Date
    April 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170341809
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT THE USER'S EXPERIENCES AND INVESTIGATION FINDINGS. THE LITERATURE REPORTS EITHER : GF-UCT180 OR TGF-UC180J WERE USED IN THIS STUDY GROUP. THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICES COULD NOT BE REVIEWED SINCE THE SERIAL NUMBERS WERE NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. CONCLUSION: NO MALFUNCTION OF ANY OLYMPUS DEVICE WAS REPORTED IN ANY PROCEDURE DESCRIBED IN THIS ARTICLE. FROM THE INFORMATION REPORTED, IT IS PRESUMED THAT THE CAUSES OF THE REPORTED EVENTS ARE NOT DUE TO PRODUCT DEFECTS, BUT THE DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238 ¿ 2022- 00366.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿A COMPARISON OF CLINICAL OUTCOMES AND COST UTILITY AMONG LAPAROSCOPY, ENTEROSCOPY, AND TEMPORARY GASTRIC ACCESS ASSISTED ERCP IN PATIENTS WITH ROUX EN Y GASTRIC BYPASS ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS IN THREE STUDY GROUPS USING DIFFERENT OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DAE GROUP AES (DEVICE: OLYMPUS SINGLE OR DOUBLE BALLOON DUODENOSCOPE-MODEL NOT SPECIFIED). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE LA-ERCP GROUP AES (DEVICE: OLYMPUS THERAPEUTIC DUODENOSCOPE-MODEL NOT SPECIFIED). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE GATE GROUP AES (DEVICE: GF-UCT180 OR TGF-UC180J). BACKGROUND AND AIMS: GASTRIC ACCESS TEMPORARY FOR ENDOSCOPY (GATE), ALSO KNOWN AS EUS-DIRECTED TRANSGASTRIC ERCP (EDGE), HAS DEMONSTRATED ADVANTAGES OVER DEVICE-ASSISTED ENTEROSCOPY (DAE) AND LAPAROSCOPIC-ASSISTED ERCP (LA-ERCP) FOR PATIENTS WITH ROUX-EN-Y GASTRIC BYPASS (RYGB) ANATOMY. WE AIMED TO DIRECTLY COMPARE CLINICAL OUTCOMES AND COST UTILITY AMONG THE THREE ERCP MODALITIES. METHOD: PATIENTS WITH RYGB ANATOMY WHO HAD DAE, LA-ERCP, OR GATE FROM 2009 TO 2019 AT 2 TERTIARY CENTERS WERE INCLUDED IN OUR REVIEW. WE MEASURED OUTCOMES IN THREE AREAS: SUCCESS RATE, POST-PROCEDURAL ADVERSE EVENTS (AES) AND HOSPITALIZATION, AND COST UTILITY PER MEDICARE/MEDICAID INSURANCE PAYMENTS. RESULTS: S COHORT TOTAL 130 PATIENTS (70 UNDERWENT DAE, 42 LA-ERCP, AND 18 GATE). SUCCESS RATE DAE WAS SUCCESSFUL IN 59% OF PATIENTS, COMPARED TO SUCCESS RATES OF 98 AND 100% FOR LA-ERCP AND GATE, RESPECTIVELY (P <0.001). FOR DAE, 62% OF UNSUCCESSFUL CASES REQUIRED RESCUE THERAPY. ADVERSE EVENTS AND HOSPITALIZATION PATIENTS WHO UNDERWENT GATE HAD THE LOWEST RATE OF HOSPITALIZATION POST PROCEDURE (44% VS. 77% AND 100% FOR DAE AND LA-ERCP, RESPECTIVELY, P<0.01) AND SPENT THE LEAST AMOUNT OF TIME HOSPITALIZED (MEDIAN TIME 0 DAYS VS 2 AND 3 DAYS FOR DAE AND LA-ERCP, RESPECTIVELY, P<0.0001). GATE HAD LOWER AE RATES THAN LA-ERCP (6 VS 31%, P=0.046), AND BOTH HAD SIMILAR RATES TO DAE. COST UTILITY LA-ERCP CARRIED THE HIGHEST TOTAL PROCEDURAL AND HOSPITALIZATION COST PER (B)(6) INSURANCE PAYMENTS (MEDIAN PAYMENT DIFFERENCE OF (B)(6) VS GATE AND (B)(6) VS DAE, P<0.01 FOR BOTH). PROCEDURAL AND HOSPITALIZATION COSTS WERE SIMILAR BETWEEN GATE AND DAE (P=0.76). CONCLUSIONS: GATE IS A SAFE MODALITY FOR ERCP WITH HIGH SUCCESS RATES IN RYGB PATIENTS AND EXHIBITS THE LOWEST HOSPITALIZATION TIME AND RATE OF ADVERSE EVENTS WHEN COMPARED TO DAE AND LA-ERCP. GATE IS SIMILAR TO DAE FROM A COST UTILITY APPROACH, AND BOTH ARE LESS COSTLY THAN LA-ERCP. ONE PATIENT IN THE GATE GROUP EXPERIENCED GASTRIC BLEEDING DUE TO STENT DISLODGMENT THAT WAS TREATED ENDOSCOPICALLY WITH NO SURGICAL INTERVENTION REQUIRED. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812765 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170341809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O