BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 14738173 · Received June 17, 2022

    Report

    Report Number
    8010047-2022-10290
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    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 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

    IT IS REPORTED IN THE LITERATURE ARTICLE TITLED ¿EUS-GUIDED CHOLEDOCHODUODENOSTOMY WITH ELECTROCAUTERY-ENHANCED LUMEN-APPOSING METAL STENTS IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION: MULTICENTER COLLABORATION FROM THE UNITED KINGDOM AND IRELAND¿, PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER PROCEDURES USING OLYMPUS DEVICES. BACKGROUND AND AIMS: EUS-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDD) WITH AN ELECTROCAUTERY-ENHANCED LUMEN-APPOSING METAL STENT (EC-LAMS) HAS EMERGED AS A VIABLE METHOD OF ESTABLISHING BILIARY DRAINAGE IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO). OUR AIM WAS TO ASSESS THE EFFICACY, SAFETY, AND OUTCOMES IN PATIENTS WITH MDBO WHO UNDERWENT EUS-CDD WITH AN EC-LAMS. METHODS: A RETROSPECTIVE REVIEW OF CONSECUTIVE PATIENTS WITH MDBO WHO UNDERWENT EUS-CDD WITH EC-LAMSS AT 8 TERTIARY INSTITUTIONS ACROSS THE UNITED KINGDOM AND IRELAND BETWEEN SEPTEMBER 2016 AND NOVEMBER 2020 WAS UNDERTAKEN. RESULTS: ONE HUNDRED TWENTY PATIENTS (55% MEN) WITH A MEDIAN AGE OF 73 YEARS (INTERQUARTILE RANGE, 17; RANGE, 43-94) WERE INCLUDED. THE MEDIAN FOLLOW-UP PERIOD IN 117 PATIENTS WAS 70 DAYS (INTERQUARTILE RANGE, 169; RANGE, 3-869), AND 23 PATIENTS (19.2%) WERE ALIVE AT THE END OF THE FOLLOW-UP. THREE PATIENTS WERE LOST TO FOLLOW-UP. TECHNICAL SUCCESS WAS ACHIEVED IN 109 PATIENTS (90.8%). CLINICAL SUCCESS (REDUCTION OF SERUM BILIRUBIN TO =50% OF ORIGINAL VALUE WITHIN 14 DAYS) WAS ACHIEVED IN 94.8% OF PATIENTS (92/97). THE ADVERSE EVENT RATE WAS 17.5% (N = 21). BILIARY REINTERVENTION AFTER INITIAL TECHNICAL SUCCESS WAS REQUIRED IN 9 PATIENTS (8.3%). CONCLUSIONS: EUS-CDD WITH EC-LAMSS AT TERTIARY INSTITUTIONS WITHIN A REGIONAL HEPATOPANCREATOBILIARY NETWORK FOR TREATMENT OF MDBO WAS EFFECTIVE IN THOSE WHERE ERCP WAS NOT POSSIBLE OR WAS UNSUCCESSFUL. WHEN TECHNICAL FAILURES OR ADVERSE EVENTS OCCUR, MOST PATIENTS CAN BE MANAGED WITH CONSERVATIVE OR ENDOSCOPIC THERAPY. THE OVERALL ADVERSE EVENT RATE WAS 17.5% (N Z 21). THE TIMING OF THE ADVERSE EVENTS WAS PERIPROCEDURAL IN 7 PATIENTS, POSTPROCEDURAL IN 6, AND LATE IN 8 PATIENTS. TECHNICAL FAILURE OCCURRED IN 11 OF 120 PATIENTS (9.2%). THIS RESULTED IN DUODENAL PERFORATION IN 2 PATIENTS. IN THE FIRST PATIENT, DESPITE BILE DRAINING VISIBLY, THE INNER FLANGE OF THE EC-LAMS WAS NOTED TO TRAVERSE THE SPACE BETWEEN THE BILE DUCT AND THE DUODENAL WALL. ACCESS TO THE BILE DUCT COULD NOT BE REGAINED, AND THE PATIENT SUBSEQUENTLY UNDERWENT LAPAROTOMY FOR SURGICAL REPAIR OF THE DEFICIT AND A BILIOENTERIC BYPASS. IN THE OTHER PATIENT, THE DUODENAL DEFECT WAS CLOSED ENDOSCOPICALLY WITH THROUGH THE-SCOPE CLIPS AND THE PROCEDURE COMPLETED BY PERFORMING A CHOLECYSTODUODENOSTOMY WITH A 10-MM EC-LAMS FOLLOWED BY DUODENAL STENT PLACEMENT TO TREAT SYMPTOMS OF GASTRIC OUTLET OBSTRUCTION. DESPITE THIS, THE PATIENT DEVELOPED PERITONITIS AND UNDERWENT A LAPAROTOMY THAT REVEALED BILIARY PERITONEAL CONTAMINATION AND A DEFECT IN THE BILE DUCT THAT WAS REPAIRED SURGICALLY. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399064 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R