BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 20048181 · Received August 23, 2024

    Report

    Report Number
    3002808148-2024-08039
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    June 3, 2024
    Report Date
    October 21, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: MEDIAN AGE IS 63 YEARS OLD. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000377. THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THE DEVICE WAS NOT RETURNED. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 REPORTED EVENT WAS LIKELY AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE WHILE USING THE SUBJECT DEVICE. HOWEVER, THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE AND NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY FOR BENIGN GASTRIC OUTLET OBSTRUCTION (GOO): A RETROSPECTIVE ANALYSIS OF PATIENTS AND OUTCOMES". LITERATURE SUMMARY: BACKGROUND AND STUDY AIMS: ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) HAS BEEN WELL UTILIZED IN TREATING MALIGNANT GASTRIC OUTLET OBSTRUCTIONS (GOO) GIVEN ITS EFFICACY AND LOWER RISK PROFILE COMPARED TO SURGERY. HOWEVER, ITS EFFICACY AND POTENTIAL FOR USE IN PATIENTS WITH BENIGN GOO WHO ARE POOR SURGICAL CANDIDATES IS NOT WELL DOCUMENTED. THE AIM OF THIS STUDY WAS TO EXAMINE THE ROLE OF EUS-GJ IN TREATMENT OF BENIGN GOO IN SELECT PATIENTS. PATIENTS AND METHODS: THIS IS A SINGLE-CENTER, OPEN-LABEL, RETROSPECTIVE DESCRIPTIVE STUDY THAT INCLUDED ALL CONSECUTIVE PATIENTS UNDERGOING EUS-GJ TO TREAT BENIGN CAUSES OF GOO. DIRECT ANTEGRADE AND DIRECT RETROGRADE METHODS WERE UTILIZED. RESULTS A TOTAL OF 18 PATIENTS WERE INCLUDED, 38.9% FEMALE WITH AN AVERAGE AGE OF 63.3 YEARS. EXTRINSIC GOO WAS PRESENT IN (10 OF 18) 55.5% OF PATIENTS AND INTRINSIC ETIOLOGY WAS PRESENT IN (8 OF 18) 45.5% OF PATIENTS. TECHNICAL SUCCESS WAS ACHIEVED IN 100% (18 OF 18) PATIENTS AND CLINICAL SUCCESS WAS ACHIEVED IN 94% (17 OF 18) PATIENTS. IN TOTAL, 13 PATIENTS HAD FOLLOW-UP ENDOSCOPY, 2 PATIENTS WERE TREATED RELATIVELY RECENTLY IN TIME, 1 PATIENT WAS LOST TO FOLLOW-UP, AND 2 PATIENTS DIED OF OTHER CHRONIC ILLNESSES. STENTS REMAINED IN PLACE FOR A MEDIAN OF 286 DAYS (RANGE 88¿1444 DAYS). IN PATIENTS WHOSE STENTS WERE REMOVED, 75% (3 OF 4) HAD EXTRINSIC ETIOLOGIES OF GOO. CONCLUSIONS: THIS STUDY REPORTS A FAVORABLE LONG-TERM PATENCY WITH EXCELLENT TECHNICAL AND CLINICAL SUCCESS OF EUS-GJ IN PATIENTS WITH BENIGN GOO. DESPITE THE LIMITATIONS OF SAMPLE SIZE AND RETROSPECTIVE NATURE, IT ADDS TO THE EXTREMELY LIMITED LITERATURE OF EUS-GJ IN MANAGEMENT OF PATIENTS WITH BENIGN GOO. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE: INTRAOPERATIVE GASTRIC BLEEDING - RESOLVED WITH INTRAOPERATIVE EPINEPHRINE INJECTION POST-OPERATIVE GASTRIC BLEEDING - RESOLVED WITH CLIPPING AND EPINEPHRINE INJECTION POST-OPERATIVE RETROPERITONEAL HEMORRHAGE - RESOLVED WITH INTERVENTIONAL RADIOLOGY EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380692 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention