BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS SMALL INTESTINAL VIDEOSCOPE SYSTEM

    MDR report key: 3428656 · Received October 18, 2013

    Report

    Report Number
    2951238-2013-00051
    Event Type
    Death
    Date Received
    October 18, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 1, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    FDA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AS IT'S WORKING PROPERLY. THE EXACT CAUSE OF THE PT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE WRONG NEEDLE WAS USED IN THE SIF-Q140 SCOPE. THE NEEDLE WOULD NOT COME OUT OF THE SCOPE AND THE PT DIED. THE USER FACILITY DID NOT ALLEGE THAT AN OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO THE PT'S OUTCOME. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING IN AN ATTEMPT TO OBTAIN MORE DETAILED INFORMATION BUT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536130 OLYMPUS SMALL INTESTINAL VIDEOSCOPE SYSTEM SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEM CORP SIF-Q140 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death US ENDOSCOPY 25 GA NEEDLE PRODUCT#00711808