BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 12966172 · Received December 9, 2021

    Report

    Report Number
    8010047-2021-15807
    Event Type
    Death
    Date Received
    December 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 0

    ON NOV. 15, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "IMPACT OF COVID-19 PANDEMIC ON KEY PERFORMANCE INDICATORS IN PANCREATOBILIARY ENDOSCOPY: PRIORITISE, MINIMISE RISK, KEEP SCOPING AND TRAINING". A RETROSPECTIVE AUDIT OF A PROSPECTIVELY MAINTAINED ENDOSCOPY DATABASE WAS CARRIED OUT BETWEEN 18 MARCH AND 31 JULY 2020. 146 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) AND 87 ENDOSCOPIC ULTRASOUND (EUS) PROCEDURES OF THE ABOVE PERIOD WERE INCLUDED IN THIS STUDY. MEDIAN AGE OF THE STUDY POPULATION WAS 71 YEARS. MAJORITY (135/233) WERE FEMALES. FOR THE ERCP, A DUODENOSCOPE(TJF-260V) WAS USED. IN THE LITERATURE FOR THE PROCEDURE, IT WAS REPORTED THAT THE FOLLOWING. POST-ERCP SPHINCTEROTOMY BLEED, POST-ERCP PANCREATITIS, POST-ERCP CHOLANGITIS, AND ERCP-RELATED MORTALITY WERE REPORTED IN 1, 7, 1, AND 1 PATIENT, RESPECTIVELY. BASED ON THE AVAILABLE INFORMATION, REPORTED POST-ERCP SPHINCTEROTOMY BLEED, POST-ERCP PANCREATITIS, POST-ERCP CHOLANGITIS, AND ERCP-RELATED MORTALITY WERE NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. HOWEVER, OMSC ASSUMES THAT THE POST-ERCP PANCREATITIS, THE POST-ERCP CHOLANGITIS, AND THE ERCP-RELATED MORTALITY MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE PROCEDURE. AND, OMSC ASSUMES THAT THE ERCP-RELATED MORTALITY MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. OMSC ASSUMES THAT POST-ERCP SPHINCTEROTOMY BLEED WAS NOT RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS NOT A SPHINCTEROTOME. OMSC ASSUMES THAT THE POST-ERCP PANCREATITIS AND THE POST-ERCP CHOLANGITIS WERE NOT SERIOUS SINCE HOSPITALIZATION WAS NOT REPORTED. THEREFORE, OMSC ASSUMES THAT THE ERCP-RELATED MORTALITY WAS ADVERSE EVENT TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENT (EXCEPT FOR SOME, FOR EXAMPLE, AGE) WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) OF THE SUBJECT DEVICE FOR THE ERCP-RELATED MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865496 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death