BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13536552 · Received February 15, 2022

    Report

    Report Number
    8010047-2022-02976
    Event Type
    Injury
    Date Received
    February 15, 2022
    Report Date
    February 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING ARTICLE: "GASTRIC OUTLET OBSTRUCTION WITH ASCITES: EUS-GUIDED GASTRO-ENTEROSTOMY IS FEASIBLE" BY JAHANGEER BASHA ET AL.   BACKGROUND AND STUDY AIMS ENDOSCOPIC ULTRASOUND-GUIDED GASTRO-ENTEROSTOMY(EUS-GE) IS A RECENTLY DESCRIBED NOVEL MINIMALLY INVASIVE ENDOSCOPIC PROCEDURE FOR PATIENTS HAVING MALIGNANT GASTRIC OUTLET OBSTRUCTION (GOO). THE SAFETY OF EUS-GE IN THE PRESENCE OF ASCITES WITH GOO IS NOT KNOWN. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE FEASIBILITY AND SAFETY OF EUS-GE IN PATIENTS WITH GOO AND ASCITES. PATIENTS AND METHODS CONSECUTIVE PATIENTS WITH GOO WHO UNDERWENT EUS-GE BETWEEN JANUARY 2019 AND MARCH 2021 CONSTITUTED THE STUDY POPULATION. EUS-GE WAS PERFORMED USING EITHER EPASS OR FREE-HAND TECHNIQUE. THE TECHNICAL SUCCESS, CLINICAL SUCCESS, ADVERSE EVENTS, AND SURVIVAL TIMES WERE EVALUATED. THE OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT ASCITES. RESULTS: A TOTAL OF 31 PATIENTS WITH GOO UNDERWENT EUS-GE OF WHOM 29 (93.5 %) HAD MALIGNANT AND TWO (6.4 %) HAD BENIGN ETIOLOGIES. ASCITES WAS OBSERVED IN 12 OUT OF 31 (38.7%) PATIENTS AND ALL HAD UNDERLYING MALIGNANCY. MAJORITY (27, 87 %) OF THE EUS-GE PROCEDURES WERE PERFORMED USING EPASS TECHNIQUE, AND 4 (13 %) UNDERWENT FREE-HAND TECHNIQUE. ELEVEN OF 12 PATIENTS WITH ASCITES AND GOO UNDERWENT EUS GE USING EPASS TECHNIQUE. THE TECHNICAL SUCCESS (91.6 % VS. 89.4 %; P = 0.841), CLINICAL SUCCESS (83.3 % VS. 89.4%; P = 0.619), MEAN PROCEDURE TIME (32 VS. 31.6 MIN; P = 0.968) AND ADVERSE EVENTS (0 % VS. 10.5 %; P = 0.245) WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN PATIENTS WITH OR WITHOUT ASCITES. HOWEVER, THE MEDIAN SURVIVAL TIME WAS SIGNIFICANTLY LOW IN PATIENTS WITH ASCITES WHEN COMPARED TO WITHOUT ASCITES (36 VS. 290 DAYS; P < 001). CONCLUSIONS: ASCITES IS A COMMON OCCURRENCE IN PATIENTS WITH MALIGNANT GOO. EUS GE IS FEASIBLE IN PRESENCE OF ASCITES WITH EPASS TECHNIQUE    THE AUTHORS USED AN OLYMPUS GF-UCT180 AND REPORTED THE FOLLOWING EVENTS: ONE PATIENT HAD COLONIC PERFORATION REQUIRING SURGERY WHILE USING THE FREE-HAND TECHNIQUE ONE PATIENT WITH BENIGN DUODENAL STRICTURE DUE TO CHRONIC PANCREATITIS AND PORTAL VEIN THROMBOSIS WITH PERI-GASTRIC COLLATERALS HAD GASTROINTESTINAL BLEEDING DURING LAMS DEPLOYMENT. GASTRIC SIDE BLEEDING WAS CONTROLLED WITH CLIPS AND JEJUNAL SIDE BLEEDING WAS CONTROLLED BY PASSING THE GASTROSCOPE THROUGH THE LAMS AND APPLYING THE CLIP OVER JEJUNAL PUNCTURE SIDE. BOTH THESE AES OCCURRED IN PATIENTS WITHOUT ASCITES. THIS REPORT IS 1 OF 1 FOR THE REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733814 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O