BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 7680603 · Received July 12, 2018

    Report

    Report Number
    8010047-2018-01324
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    February 22, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED BY THE FACILITY. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THIS REPORT. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON JUNE 20TH, 2018, OLYMPUS RECEIVED LITERATURE TITLED ¿THE MODIFIED PANCREATIC STENT SYSTEM FOR PREVENTION OF POST-ERCP PANCREATITIS: A CASE-CONTROL STUDY.¿ THAT WAS MADE IN PUBLIC IN BIOMED CENTRAL GASTROENTEROLOGY. THE AIM OF THE LITERATURE WAS TO INVESTIGATE THE FEASIBILITY AND EFFECTIVENESS OF A NON-OLYMPUS MODIFIED PANCREATIC STENT SYSTEM FOR PREVENTION OF POST-ERCP PANCREATITIS. THE LITERATURE REPORTED THE RESULT OF 230 CASES OF THE ENDOSCOPIC PROCEDURE USING THE PANCREATIC STENT SYSTEM AND OLYMPUS DUODENOSCOPE BETWEEN NOVEMBER 2013 TO NOVEMBER 2015. IN THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED. IN ORDINARY GROUP(USING NORMAL STENT): 5 CASES OF ACUTE PANCREATITIS AND 7 CASES OF HYPERAMYLASEMIA. AFTER REMOVING THE PROXIMAL MIGRATORY STENT, 4 CASES OF ACUTE PANCREATITIS AND 5 CASES OF HYPERAMYLASEMIA. IN A MODIFIED GROUP(USING MODIFIED STENT): 2 CASES OF ACUTE PANCREATITIS AND 3 CASES OF HYPERAMYLASEMIA. AS THE ENDOSCOPIC EQUIPMENT USED FOR THE STUDY, OLYMPUS CONFIRMED THAT JF-260V AND TJF-240 (OLYMPUS) WERE DESCRIBED IN THE LITERATURE. OLYMPUS IS SUBMITTING MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF SERIOUS COMPLICATIONS (11 CASES OF ACUTE PANCREATITIS) BECAUSE HYPERLIPIDEMIA IS GENERALLY KNOWN TO BE NOT A SERIOUS INJURY. THIS REPORT IS 5 OF 11 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525145 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other