BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8010047-2017-01703

    MDR report key: 7012527 · Received November 9, 2017

    Report

    Report Number
    8010047-2017-01703
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    March 25, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION OF THE SUBJECT DEVICES CONCERNING THIS CASE HAS NOT BEEN REPORTED. ALSO, SINCE THE SERIAL NUMBERS OF THESE DEVICES ARE UNKNOWN, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT CONFIRM THE MANUFACTURING HISTORY. BECAUSE THE USER FACILITY RECOGNIZED AS ACCIDENTAL SYMPTOM IN THE CONCLUSION OF THE REPORT, THIS CASE IS NOT THE MALFUNCTION OF DEVICE, IT SEEMS TO BE ACCIDENTAL SYMPTOM. BUT THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REPORTED AT THE 25TH JAPAN DIGESTIVE DISEASE WEEK (JDDW 2017). ARTICLE TITLE: TREATMENT RESULTS OF INTRAHEPATIC STONE IN OUR DEPARTMENT THE ARTICLE STUDIED ON TREATMENT STRATEGY FOR INTRAHEPATIC STONE INCLUDING ELECTROHYDRAULIC LITHOTRIPSY (EHL) IN 75 CASES THAT UNDERWENT MEDICAL TREATMENT FOR INTRAHEPATIC STONE PERFORMED SINCE 1995. [REPORT SUMMARY] IN THE 75 CASES, AN ENDOSCOPIC TREATMENT VIA PAPILLA USING A DUODENOSCOPE OR A DOUBLE- BALLOON ENDOSCOPE (SINCE 2008) PRECEDED. IN THE CASES WHERE AN ENDOSCOPIC TREATMENT WAS DIFFICULT, PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) OR AN ENDOSCOPIC TREATMENT WITH EHL WAS CONDUCTED. CHF-T20, CHF-XP20 OR CHF-BF260 WERE USED AS CHOLANGIOSCOPE. IN THE SUBJECT PROCEDURES, ACCIDENTAL SYMPTOMS OCCURRED AS FOLLOWS. - ENDOSCOPIC TREATMENT GROUP: 3CASES OF CHOLANGITIS - PTBD-ALONE GROUP: 3CASES OF CHOLANGITIS - EHL GROUP: 5CASES OF ACUTE CHOLANGITIS, 2CASES OF HEMOBILIA [CONCLUSION] THERE ARE MANY CASES WHERE AN INTRAHEPATIC STONE REMOVAL WAS CONDUCTED AFTER A TREATMENT OF THE BILE DUCT. IN TREATMENT CASES WITH ENDOSCOPE ALONE, 9 OUT OF 36 (25%) WERE ABLE TO ACHIEVE STONE-FREE AND THE RATE OF STONE FRAGMENTATION WAS LOW. IN THE EHL TREATMENT, 42 OUT OF 47 WERE ABLE TO ACHIEVE STONE-FREE, THEREFORE EHL TREATMENT IS CONSIDERED AS AN EFFECTIVE TREATMENT. THIS IS 3 OF 3 REPORTS. (ENDOSCOPIC TREATMENT GROUP: CHOLANGITIS 3 OF 3 REPORTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794517 FBN OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other