BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 8526828 · Received April 18, 2019

    Report

    Report Number
    8010047-2019-01728
    Event Type
    Death
    Date Received
    April 18, 2019
    Report Date
    April 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170229459
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC. OMSC COULD NOT REVIEW SERVICE AND MANUFACTURING RECORDS BECAUSE THE SERIAL NUMBERS OF THE SUBJECT DEVICES WERE NOT PROVIDED FROM THE FACILITY. AS PART OF OUR INVESTIGATION, OMSC REVIEWED ALL OF THE COMPLAINTS, BUT THERE WAS NO RECORD ASSOCIATED WITH THE EVENT DESCRIBED IN THE ARTICLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON MARCH 20, 2018, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿PALLIATION OF MALIGNANT GASTRODUODENAL OBSTRUCTION WITH SELF-EXPANDABLE METAL STENT USING SIDE- AND FORWARD-VIEWING ENDOSCOPE: FEASIBILITY AND OUTCOME¿. THE LITERATURE REPORTED THE RESULT OF 114 CASES OF THE SELF-EXPANDABLE METAL STENT (SEMS) PROCEDURES USING AN OLYMPUS GASTROINTESTINALVIDEOSCOPE MODEL GIF-2TH180 (24 CASES) AS FORWARD VIEWING ENDOSCOPE AND DUODENOVIDEOSCOPE MODEL TJF-150 (90 CASES) AS SIDE VIEWING ENDOSCOPE BETWEEN FEBRUARY 2012 AND JANUARY 2017. IN THE SUBJECT PROCEDURES USING THE TJF-150, 1 CASE OF DIED OF MASSIVE TUMOR-RELATED BLEED AND 2 CASES OF ASPIRATION PNEUMONIA OCCURRED, WHILE THERE WAS NO COMPLICATION IN PROCEDURES USING THE GIF-2TH180. THE BACKGROUND AND METHOD OF THE LITERATURE ARE AS FOLLOWS; BACKGROUND: THE ENDOSCOPIC PLACEMENT OF A SELF-EXPANDABLE METAL STENT (SEMS), AN ALTERNATIVE TO SURGICAL BYPASS FOR THE PALLIATION OF MALIGNANT GASTRIC OUTLET OBSTRUCTION (GOO), IS COMMONLY PERFORMED USING A FORWARD-VIEWING ENDOSCOPE WITH A WIDE THERAPEUTIC CHANNEL; HOWEVER, DUE TO LIMITED AVAILABILITY, MOST INDIAN CENTERS USE A SIDEVIEWING DUODENOSCOPE. WE STUDIED THE FEASIBILITY AND OUTCOME OF SEMS PLACEMENT USING SIDE- AND FORWARD-VIEWING ENDOSCOPES. METHOD: DATA OF PATIENTS UNDERGOING SEMS PLACEMENT USING SIDE- AND FORWARDVIEWING ENDOSCOPES WITH A THERAPEUTIC CHANNEL FOR THE PALLIATION OF MALIGNANT GOO PRESENTING DURING A 5-YEAR PERIOD WERE ANALYZED RETROSPECTIVELY. FOLLOW-UP DATA WERE OBTAINED FROM RECORDS AND TELEPHONIC INTERVIEWS, AND TECHNICAL AND CLINICAL SUCCESS, COMPLICATIONS, AND SURVIVAL WERE EVALUATED. THE STENT USED IN THE LITERATURE WERE WALLFLEX (BOSTON SCIENTIFIC), HANARO (M. I. TECH 174), NITI-S (TAEWOONG MEDICAL), BONASTENT (STANDARD SCI-TECH INC.) AND OTTOMED (MITRA MEDICAL SERVICES LLP). OMSC TRIED TO OBTAIN DETAILED INFORMATION, BUT ADDITIONAL INFORMATION HAS NOT BEEN OBTAINED AT THE PRESENT. THEREFORE, OMSC IS SUBMITTING MDR ACCORDING TO THE NUMBER OF THE COMPLICATION CASES. THIS IS 1 OF 3 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319971 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-150 04953170229459

    Patients

    Seq Age Sex Outcome Treatment
    1 Death