BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 15080197 · Received July 21, 2022

    Report

    Report Number
    3001722928-2022-00016
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    September 27, 2020
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    PMA / PMN Number
    K183032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENTS IN THE LITERATURE "GASTROENTEROLOGICAL ENDOSCOPY 2022; 64:1273-86. MASAAKI SHIMATANI: RECENT ADVANCES IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING BALLOON-ASSISTED ENDOSCOPY FOR PANCREATICOBILIARY DISEASES IN PATIENTS WITH SURGICALLY ALTERED ANATOMY: THE THERAPEUTIC STRATEGY AND MANAGEMENT OF DIFFICULT CASES." ARE DESCRIBED AS FOLLOWS: THE COMMON TYPES OF COMPLICATIONS FOR BAE-ERCP ARE BLEEDING, PERFORATION, AND POST-ERCP PANCREATITIS, ALMOST EQUIVALENT TO THOSE OF CONVENTIONAL ERCP, THOUGH COMPLICATIONS SPECIFIC TO BAE-ERCP SUCH AS HEPATIC PORTAL VENOUS GAS HAVE ALSO BEEN REPORTED. A RETROSPECTIVE STUDY BY TOKUHARA ET AL. REPORTED THAT THE OVERALL OCCURRENCE WAS 5.8% AND THE MOST COMMON ADVERSE EVENT WAS PERFORATION IN 3.2%. ANOTHER MULTI-CENTER PROSPECTIVE STUDY THAT EVALUATED MORE THAN 300 DBE PROCEDURES REPORTED THE COMPLICATION RATE WAS 10.6% INCLUDING PERFORATION WHICH WAS THE MOST COMMON ADVERSE EVENT, OCCURRING IN 3.9%. THE MAIN COMPLICATION IN CONVENTIONAL ERCP WAS POST-ERCP PANCREATITIS, WHILE, IN BAE-ERCP IT WAS PERFORATION. IN THE INSTRUCTION MANUAL OF THIS PRODUCT, THE NECESSARY WARNINGS RELATED TO THE PERFORATION AS THE MAIN COMPLICATION HAVE BEEN DESCRIBED AS FOLLOWS: - IF YOU ENCOUNTER ANY RESISTANCE DURING A PROCEDURE, INSERT THE ENDOSCOPE SLOWLY. DO NOT FORCE IT IN. DO NOT INSERT OR BEND THE ENDOSCOPE WITHOUT SECURING THE VIEW ON THE MONITOR. NOT FOLLOWING THE RECOMMENDATIONS ABOVE MAY CAUSE INJURY TO TISSUES IN THE BODY CAVITY, BLEEDING, OR PERFORATION. DO NOT APPLY THE EXCESSIVE FORCE OF THE ENDOSCOPE OR ENDOTHERAPY DEVICE AGAINST MUCOSAL SURFACES. DOING SO MAY CAUSE INJURY TO TISSUES IN THE BODY CAVITY, BLEEDING, AND/OR PERFORATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO FDA AS A RESULT OF FUJIFILM CORPORATION'S COMMITMENT TO PERFORM A RETROSPECTIVE REVIEW OF ALL MDRS SUBMITTED BETWEEN OCTOBER 1, 2021 AND OCTOBER 12, 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON SEPTEMBER 22, 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2022 FUJIFILM CORPORATION BECAME AWARE OF ADVERSE EVENTS MENTIONED IN LITERATURE RELATED TO ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING BALLOON-ASSISTED ENDOSCOPY. THERE WAS NO DEATH REPORTED IN THIS LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89548 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT DUODENOSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EI-580BT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other