BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULA

    MDR report key: 8171833 · Received December 17, 2018

    Report

    Report Number
    8010047-2018-02445
    Event Type
    Injury
    Date Received
    December 17, 2018
    Report Date
    December 18, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODD
    PMA / PMN Number
    K950729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MALFUNCTION OF THE SUBJECT DEVICE WAS NOT REPORTED. THE SUBJECT DEVICE IS DONE THE 100% INSPECTION. THE AUTHOR HAS NOT PROVIDED ADDITIONAL INFORMATION ABOUT INDIVIDUAL CASES. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC ASSUMES THAT THE CAUSE OF THIS EVENT IS NOT RELATED TO THE MALFUNCTION OF THE DEVICE. IT WAS KNOWN THAT THE ENDO-THERAPY DEVICES USING FOR THE BILIARY OR PANCREATIC TREE COULD LEAD TO A PANCREATITIS. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY NOTED AS FOLLOWS; LIMITED STUDIES INDICATE THAT: ACUTE PANCREATITIDES ARE CAUSED MOST FREQUENTLY AS CASES OF POST- DIAGNOSTIC ERCP, AND THAT 50% OF THE CAUSES OF DEATHS ARE MADE UP OF PANCREATITIS¿ BECOMING SEVERE; THIS IS FOLLOWED BY PERFORATION, AND MOST OF THE SITE OF PERFORATION ARE DESCENDING LIMB. LIMITED STUDIES INDICATE THAT ACUTE PANCREATITIDES FOLLOWING ERCP ARE MOSTLY MILD CASES; HOWEVER, ONCE IN A WHILE, SEVERE CASES EXIST, IN WHICH FAILURE OF MULTIPLE ORGANS AND DISSEMINATED INTRAVASCULAR COAGULATION ARE DEVELOPED SUCCESSIVELY LEADING TO DEATH.

    Description of Event or Problem · 1

    IN THE PAPER "EFFICACY AND SAFETY OF PANCREATIC JUICE CYTOLOGY BY USING SYNTHETIC SECRETIN IN THE DIAGNOSIS OF PANCREATIC DUCTAL ADENOCARCINOMA", PUBLISHED IN THE JOURNAL "DIGESTIVE ENDOSCOPY 2018; 30: 771-776", THE FOLLOWING WERE REPORTED; 138 CASES OF PANCREATIC JUICE CYTOLOGY (PJC) WERE DONE TO DETECT THE PANCREATIC DUCTAL ADENOCARCINOMA (PDAC). THE SUBJECT PRODUCT OR (B)(4) (BOSTON SCIENTIFIC) WAS USED FOR PJC. 12 PATIENTS SUFFERED MILD PANCREATITIS AS A COMPLICATION. ALL 12 PATIENTS WERE IMMEDIATELY CURED WITH CONSERVATIVE MEDICAL TREATMENT. IT WAS UNKNOWN WHETHER THE SUBJECT PRODUCT WAS USED IN THE MILD PANCREATITIS-OCCURRED CASES. THE MALFUNCTION OF THE SUBJECT PRODUCT WAS NOT REPORTED. THIS IS THE REPORT REGARDING THE OCCURRING OF THE PANCREATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009975 CANNULA CANNULA ODD OLYMPUS MEDICAL SYSTEMS CORP. PR-110Q-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other