BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 14164391 · Received April 20, 2022

    Report

    Report Number
    8010047-2022-06733
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    January 21, 2021
    Report Date
    May 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION. THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238- 2022- 00382.

    Additional Manufacturer Narrative · 0

    EVENT DATE UPDATED TO REFLECT PUBLICATION DATE OF SOURCE ARTICLE. 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 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    HOLD FOR AG 6.23.2022 IT IS REPORTED IN THE LITERATURE TITLED: ¿ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY VERSUS OPEN SURGICAL GASTROJEJUNOSTOMY: CLINICAL OUTCOMES AND COST EFFECTIVENESS ANALYSIS,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING AND AFTER ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY (EUS-GE) PROCEDURES USING OLYMPUS GASTROSCOPES. CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS EUS-GE GROUP (GIF-1TH190) AES; CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS EUS-GE (GIF-1TH190) 30-DAY MORTALITY; CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS EUS-GE (GF-UCT180) AES; CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS EUS-GE (GF-UCT180) 30-DAY MORTALITY. STUDY BACKGROUND/AIM: EARLY DATA SUGGESTS THAT ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY (EUS-GE) IS A SAFE AND EFFICACIOUS OPTION FOR GASTRIC OUTLET OBSTRUCTION (GOO). HOWEVER, THERE IS A SCARCITY OF DATA COMPARING OUTCOMES WITH OPEN GASTROJEJUNOSTOMY (OGJ). METHOD: SINGLE-CENTER RETROSPECTIVE COHORT STUDY OF ADULT PATIENTS HOSPITALIZED WITH GOO WHO UNDERWENT EUS-GE OR OGJ BETWEEN (B)(6) 2014, AND (B)(6) 2020. PRIMARY OUTCOMES WERE TECHNICAL AND CLINICAL SUCCESS. RESULTS: SIXTY-SIX PATIENTS WERE INCLUDED OF WHICH 40 (60.0%) UNDERWENT EUS-GE AND 26 (40.0%) UNDERWENT OGJ. BASELINE CHARACTERISTICS WERE SIMILAR WITH RESPECT TO AGE (70.5 VS 69.7, P=0.81), SEX (42.5% VS 42.3% FEMALE, P=0.99), MEDIAN LENGTH OF FOLLOW-UP (98.0 VS 166.5 DAYS, P=0.8), PRIOR FAILED INTERVENTION FOR GOO (22.5% VS 26.9%, P=0.68), AND THE PRESENCE OF ALTERED ANATOMY (12.5% VS 30.8%, P=0.07) BETWEEN EUS-GE AND OGJ, RESPECTIVELY. TECHNICAL SUCCESS WAS ACHIEVED IN 37 (92.5%) OF EUS-GE AND 26 (100%) OF OGJ PATIENTS (P=0.15). EUS-GE WAS ASSOCIATED WITH FASTER RESUMPTION OF ORAL INTAKE (1.3 VS 4.7 DAYS, P<0.001). CONCLUSION: THERE WERE NO SIGNIFICANT DIFFERENCES IN TECHNICAL OR CLINICAL SUCCESS, SYMPTOM RECURRENCE, REINTERVENTION, 30-DAY READMISSION, OR 30-DAY MORTALITY BETWEEN EUS-GE AND OGJ. EUS-GE PATIENTS EXPERIENCED SHORTER DELAYS TO RESUMPTION OF ORAL INTAKE AND CHEMOTHERAPY, HAD SHORTER LENGTHS OF STAY, AND REDUCED HOSPITAL COSTS. FURTHER PROSPECTIVE COMPARATIVE STUDIES ARE WARRANTED TO VERIFY OUR RESULTS. THIS RETROSPECTIVE COHORT STUDY IS THE LARGEST STUDY TO DATE AND DEMONSTRATES COMPARABLE HIGH TECHNICAL AND CLINICAL SUCCESS RATES BETWEEN EUS-GE AND OGJ, SIMILAR TO A PRIOR COMPARATIVE STUDY. RATES OF SYMPTOM RECURRENCE, REINTERVENTION, AND 30-DAY READMISSION WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS. ALTHOUGH A NEARLY FOUR-FOLD DIFFERENCE IN 30-DAY MORTALITY WAS SEEN BETWEEN OGJ (3.8%) AND EUS-GE (12.5%), THIS DID NOT REACH STATISTICAL SIGNIFICANCE. THIS LACK OF SIGNIFICANCE LIKELY REFLECTS THE LOW OVERALL NUMBER OF EVENTS. FURTHERMORE, A DIFFERENCE IN MORTALITY BETWEEN GROUPS WAS NOT ANTICIPATED GIVEN THE LARGELY TERMINALLY ILL PATIENT POPULATION WITH SHORT LIFE EXPECTANCY. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958568 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other