BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8774393 · Received July 10, 2019

    Report

    Report Number
    8010047-2019-02464
    Event Type
    Injury
    Date Received
    July 10, 2019
    Report Date
    July 10, 2019
    Manufacturer
    UNKNOWN
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS 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 FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿TREATMENT OUTCOME OF ENDOSCOPIC PAPILLA RESECTION FOR DUODENAL PAPILLARY NEOPLASMY¿. THE LITERATURE REPORTED THE RESULT OF 144 CASES OF THE ENDSCOPIC PAPILLARY LARGE BALLOON DILATION (EPLBD) PROCEDURES WITHOUT ENDOSCOPIC SPHINCTEROTOMY (EST) FOR PATIENTS WITH LARGE BILE DUCT STONE USING OLYMPUS DUODENOVIDEOSCOPE MODEL JF-260V OR TJF-260V AND BOSTON SCIENTIFIC BILIARY DILATATION BALLOON CATHETER MODEL CRE PRO FROM MARCH 2008 TO DECEMBER 2017. IN THE SUBJECT CASES, 9 CASES OF PANCREATITIS AND 1CASE OF ASPIRATION PNEUMONIA OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THEREFORE, OMSC IS SUBMITTING A TOTAL OF 10 MDRS FOR THE REPORTED EVENTS. THIS REPORT IS FOR 3 OF 9 REPORTS FOR PANCREATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568035 UNKNOWN UNKNOWN FDT UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other