BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 20384451 · Received October 7, 2024

    Report

    Report Number
    9610595-2024-20233
    Event Type
    Death
    Date Received
    October 7, 2024
    Date of Event
    January 12, 2022
    Report Date
    January 28, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 AND/OR LOT 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 REPORTED EVENT WAS LIKELY AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE WHILE USING THE SUBJECT DEVICE. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE AND NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "A HIGH-VOLUME ERCP SERVICE LED BY SURGEONS IS ASSOCIATED WITH GOOD OUTCOMES AND MEETS NATIONAL KEY PERFORMANCE INDICATORS: RESULTS FROM A BRITISH DISTRICT GENERAL HOSPITAL." LITERATURE SUMMARY: BACKGROUND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS A COMMON, BUT TECHNICALLY CHALLENGING PROCEDURE USED IN THE MANAGEMENT OF HEPATOPANCREATICOBILIARY (HPB) DISEASE. IT IS TRADITIONALLY PERFORMED BY MEDICAL GASTROENTEROLOGISTS. IN 2014, THE BRITISH SOCIETY OF GASTROENTEROLOGY (BSG) PROPOSED KEY PERFORMANCE INDICATORS TO EVALUATE AND SET STANDARDS OF ERCP PRACTICE. THIS STUDY AIMED TO COMPARE OUR ERCP OUTCOMES AGAINST THESE TARGETS, IN A CENTER WHERE ERCP IS EXCLUSIVELY PERFORMED BY SURGEONS. METHODS A RETROSPECTIVE ANALYSIS OF ALL ERCPS UNDERTAKEN OVER 38 MONTHS IN A DISTRICT GENERAL HOSPITAL IN THE UNITED KINGDOM (UK), BY THREE UPPER GASTROINTESTINAL SURGEONS. STUDY OUTCOMES WERE BASED UPON, AND COMPARED AGAINST, BSG KEY PERFORMANCE INDICATORS, INCLUDING NUMBER OF ERCPS PER ANNUM, PROPORTION OF SUCCESSFUL CANNULATIONS OF BILE DUCT AND STONE CLEARANCE, ERCP-SPECIFIC COMPLICATIONS AND MORTALITY. RESULTS THE UNIT¿S CASELOAD OVER THIS PERIOD WAS 1324, EQUATING TO APPROXIMATELY 418 PER ANNUM (BSG MINIMUM 200 PER UNIT). MANAGEMENT OF BILE DUCT STONES WAS THE COMMONEST INDICATION FOR ERCP. OVERALL, 95% (1253/1324) OF BILE DUCTS WERE CANNULATED AND 92% (645/698) FOR THOSE UNDERGOING THEIR FIRST ERCP. BILE DUCT CLEARANCE WAS ACHIEVED IN 80% OF PATIENTS (BSG RECOMMEND > 75%) AND THE SUCCESSFUL STENTING OF EXTRA-HEPATIC STRICTURES IN 94% (BSG RECOMMEND > 80%). THE OVERALL COMPLICATION RATE WAS 4.3% (BSG STANDARD < 6%). PROCEDURE-SPECIFIC MORTALITY WAS 0.3% (4/1324) WHERE DEATH WAS EITHER CAUSED BY PANCREATITIS OR SEPSIS. CONCLUSION A HIGH-VOLUME ERCP SERVICE LED AND PERFORMED EXCLUSIVELY BY SURGEONS MEETS ALL BSG PERFORMANCE INDICATORS, WITH GOOD PROCEDURAL AND PATIENT OUTCOMES. FORMAL TRAINING PATHWAYS SHOULD BE DEVELOPED TO ENCOURAGE MORE SURGICAL CENTERS TO PROVIDE AN ERCP SERVICE AND DEAL WITH WHAT ARE COMMON SURGICAL PATHOLOGIES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PANCREATITIS - 3.1%, CHOLANGITIS - 0.8%, BLEEDING - 0.2%, PERFORATION - 0.2%. PROCEDURE-SPECIFIC MORTALITY - 4 PATIENTS. OVERALL STUDY 30-DAY MORTALITY - 7 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246726 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Death| R