BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE

    MDR report key: 8022910 · Received October 31, 2018

    Report

    Report Number
    8010047-2018-02096
    Event Type
    Death
    Date Received
    October 31, 2018
    Date of Event
    September 25, 2018
    Report Date
    March 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SIF-H290S AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTION OF THE SUBJECT DEVICE ALREADY WARNS;¿ WHEN USING THE ENDOSCOPE, MAKE APPROPRIATE JUDGMENTS AND TREATMENTS FROM TRAINED SPECIALIST VIEWPOINTS TO AVOID COMPLICATIONS SUCH AS BLEEDING, PERFORATION, OR PANCREATITIS. A MEDICAL LITERATURE REPORTS THAT THE INCIDENCE OF COMPLICATIONS SUCH AS GASTROINTESTINAL PERFORATION IS 5¿10% WHEN USING AN ENDOSCOPE FOR A PATIENT WITH ALTERED ANATOMY. IF ANY COMPLICATION IS OBSERVED, IMMEDIATELY STOP THE ENDOSCOPY/TREATMENT AND TAKE PROPER MEASURES.¿

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERCP) FOR A PATIENT, WHO HAD EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY, THE DUODENUM AND THE ESOPHAGUS OF THE PATIENT WERE PERFORATED AND THE PATIENT DIED SEVERAL DAYS AFTER THE ERCP PROCEDURE. IT WAS ALSO REPORTED THAT OLYMPUS SLIDING TUBE (ST-SB1S) AND SIGMOID VIDEOSCOPE (SIF-H290S) WERE USED IN THE ERCP PROCEDURE. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION, BUT THE USER FACILITY DENIED PROVIDING DETAILED FURTHER INFORMATION ON THE EVENT. IN ADDITION, THERE WAS NO REQUEST FROM THE USER FACILITY TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866200 EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE SMALL INTESTINALVIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-H290S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death