BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJINON

    MDR report key: 1970334 · Received January 14, 2011

    Report

    Report Number
    2431293-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 13, 2011
    Manufacturer
    FUJINON, INC.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT COLONSCOPE WAS INSPECTED FOR ABNORMALITIES BY THE MANUFACTURER AND FOUND THAT THE SCOPE WAS PHYSICALLY AND FUNCTIONALLY SATISFACTORY AND THAT NOTHING RELATED TO THE SCOPE COULD HAVE CAUSED A PERFORATION OF THE BOWEL. THE STIFFNESS OF THE INSERTION SECTION WAS CHECKED BY COILING IT INTO AN 8 INCH RADIUS. THE COLONOSCOPE PASSED THIS TEST. INTERNAL DOCUMENTATION NOTED THAT MR (B)(6) REPORTED A "TEAR IN LOWER BOWEL". FUJINON INC ATTEMPTED SEVERAL TIMES TO CONTACT THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION BUT WAS UNSUCCESSFUL. THERE WERE NO PREVIOUS REPAIRS OR PATIENT INJURIES FOR THIS SN SCOPE. THIS CUSTOMER HAS OWNED THE SUBJECT SCOPE SINCE SEPTEMBER 2010. THERE ARE NO OTHER INCIDENCES OF THIS NATURE FOR THIS MODEL SCOPE.

    Description of Event or Problem · 1

    THE FACILITY RETURNED A COLONOSCOPE TO THE MANUFACTURER'S SERVICE DEPT AND NOTED "SCOPE WAS USED IN CASE INVOLVING POSSIBLE PERFORATION" ON THE SERVICE/ RETURN NOTIFICATION FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON COLONOSCOPE FDF FUJINON, INC. EC-530HL

    Patients

    Seq Age Sex Outcome Treatment
    1