BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 22926194 · Received August 29, 2025

    Report

    Report Number
    3002808148-2025-14288
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    February 12, 2024
    Report Date
    October 1, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON FINAL INVESTIGATION. UPDATED FIELDS: H2, H6. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT WAS CONFIRMED THAT THE ABDOMINAL PAIN (2 PATIENTS) AND CHOLANGITIS (1 PATIENT) OCCURRED AT THE ENDOSCOPIC ULTRASOUND (EUS) GUIDED LOWER HEPATOGASTRIC FISTULA CREATION SURGERY (HGS) AND THE TRANSCATHETER ANTEROGRADE DRILL DILATATION BY USING THE DEVICE IN QUESTION. THERE IS NO INFORMATION ABOUT DETAILED USING STATUS OF THE DEVICE AND THE OCCURRENCE OF HEALTH HAZARDS, AND THE MALFUNCTIONS OF THE PRODUCT IN QUESTION HAVE NOT BEEN REPORTED, A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT IN QUESTION AND THE HEALTH HAZARDS COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). E1 - INITIAL REPORTER ESTABLISHMENT NAME:(B)(6). SINCE THE LITERATURE STATED "ECHOENDOSCOPE (UCT260)", OLYMPUS SELECTED ¿GF-UCT180¿ AS THE REPRESENTATIVE MODEL AND INITIATED A COMPLAINT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿TRANSLUMINAL ANTEGRADE DRILL DILATION TECHNIQUE FOR HEPATICOJEJUNOSTOMY STRICTURE WITH CHOLANGIOSCOPIC EVALUATION (WITH VIDEO)¿. BACKGROUND AND STUDY AIMS . BALLOON DILATION AND PLASTIC STENT DEPLOYMENT HAVE BEEN PERFORMED AS HEPATICOJEJUNOSTOMY STRICTURE (HJS) TREATMENT TECHNIQUES UNDER ENDOSCOPIC ULTRASOUND GUIDANCE (EUS). ALTHOUGH THESE TECHNIQUES HAVE SHOWN FAVORABLE CLINICAL RESULTS, THE TREATMENT PERIOD CAN BE LONG BECAUSE STENT DEPLOYMENT IS REQUIRED. IN ADDITION, HJS MAY RECUR EVEN AFTER TREATMENT BECAUSE THE SCAR TISSUE ITSELF REMAINS. TO OVERCOME THESE CHALLENGES, WE DEVELOPED AN EUS-GUIDED ANTEGRADE DRILL DILATION TECHNIQUE FOR TREATING HJS. THE AIM OF THIS STUDY WAS TO EVALUATE THE TECHNICAL FEASIBILITY AND SAFETY OF THIS TECHNIQUE IN TERMS OF THE PRE- AND POST-CHOLANGIOSCOPIC FINDINGS. METHODS: THIS RETROSPECTIVE STUDY INCLUDED CONSECUTIVE PATIENTS WHOSE CONDITIONS WERE COMPLICATED WITH SYMPTOMATIC HJS BETWEEN NOVEMBER 2022 AND FEBRUARY 2023. TRANSLUMINAL ANTEGRADE DRILL DILATION (TAD) USING A NOVEL DRILL DILATOR WAS ATTEMPTED WITHIN 14 DAYS AFTER EUS-GUIDED HEPATICOGASTROSTOMY (HGS). HJS WAS DIAGNOSED WITH CHOLANGIOSCOPY BEFORE TAD, AND RESOLUTION WAS EVALUATED AFTER TAD USING CHOLANGIOSCOPY. RESULTS: TAD WAS ATTEMPTED AT APPROXIMATELY 11 DAYS AFTER EUS-HGS. THE CHOLANGIOSCOPE WAS INSERTED SUCCESSFULLY IN ALL PATIENTS AFTER THIS PROCEDURE. CHOLANGIOSCOPY REVEALED STRICTURE WITHOUT EVIDENCE OF MALIGNANCY IN 19 PATIENTS. IN THE REMAINING THREE PATIENTS, STRICTURE WAS NOT OBSERVED AND THESE PATIENTS UNDERWENT STENT EXCHANGE RATHER THAN TAD. AMONG THE 19 PATIENTS, PASSAGE OF THE GUIDEWIRE ACROSS THE HJS INTO THE INTESTINE WAS UNSUCCESSFUL IN FOUR PATIENTS, AND THE TECHNICAL SUCCESS RATE FOR THIS PROCEDURE WAS 78.9%. TAD WAS SUCCESSFUL IN ALL 15 PATIENTS IN WHOM PASSAGE OF THE GUIDEWIRE WAS ACHIEVED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. CHOLANGITIS (1 PATIENT). ABDOMINAL PAIN (2 PATIENTS). CONCLUSIONS: IN CONCLUSION, TAD APPEARS TO BE TECHNICALLY FEASIBLE AND SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880421 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown E0018450AG-2.| G-240-2545S.| NA-U200H-8019.| TES0025S.