BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14164370 · Received April 20, 2022

    Report

    Report Number
    8010047-2022-06732
    Event Type
    Death
    Date Received
    April 20, 2022
    Date of Event
    January 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170343360
    PMA / PMN Number
    K112680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED REPORT ADVERSE EVENTS AND TO PROVIDE INVESTIGATION RESULTS NO PHYSICAL EVALUATION/INSPECTION COULD BE CONDUCTED ON THE SUSPECT DEVICE AS IT WAS NOT RETURNED TO OLYMPUS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. THERE WAS NO REPORT OF OLYMPUS DEVICE MALFUNCTION AND NO INFORMATION CONNECTING THE CAUSE OF THE REPORTED EVENTS TO THE DEVICE. FOR THESE REASONS, THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE DETERMINED. THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238-2022-00381.

    Description of Event or Problem · 0

    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)(6) REPORTS EUS-GE GROUP (GIF-1TH190) AES; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS EUS-GE (GIF-1TH190) 30-DAY MORTALITY; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS EUS-GE (GF-UCT180) AES; CASE WITH PATIENT IDENTIFIER (B)(6) 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 JANUARY 1, 2014, AND FEBRUARY 28, 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
    1957405 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-1TH190 04953170343360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death