BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 15092916 · Received July 25, 2022

    Report

    Report Number
    1000513161-2022-00009
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    September 27, 2020
    Report Date
    July 25, 2022
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON JULY 13, 2022 FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF ADVERSE EVENTS MENTIONED IN LITERATURE RELATED TO ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING BALLOON-ASSISTED ENDOSCOPY. 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. A COPY OF 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" IS ATTACHED FOR REFERENCE AS FILE ATTACHMENT. THERE WAS NO DEATH REPORTED IN THIS LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115843 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT DUODENOSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other