BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM COLONOSCOPE EC-530LS2

    MDR report key: 9181163 · Received October 11, 2019

    Report

    Report Number
    1000513161-2019-00009
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    August 14, 2019
    Report Date
    December 6, 2019
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REF: INTERNAL COMPLAINT NUMBER (B)(4). ADDITIONAL INFORMATION: ON 12 NOV 2019 THE CUSTOMER INDICATED THAT THE THIRD PARTY LAB CULTURING RESULTS REVEALED THAT THERE WAS NO GROWTH. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 13 SEP 2019 FUJIFILM MEDICAL SYSTEMS U.S.A., INC (FMSU) WAS NOTIFIED BY (B)(6) CENTER THAT ONE (1) PATIENT WAS REPORTED TO HAVE DEVELOPED AN INFECTION, C. DIFF (CLOSTRIDIOIDES DIFFICILE), AFTER A COLONOSCOPY PROCEDURE WITH A FUJIFILM COLONOSCOPE. THE CUSTOMER INDICATED TO FMSU THAT THEY WANTED TO ELIMINATE THE COLONOSCOPE AS A POSSIBLE CAUSE OF THE INFECTION. THE PROCEDURE WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT MENTIONED TO THE CUSTOMER THAT THEY HAD DIARRHEA IMMEDIATELY AFTER THE PROCEDURE AND IT WAS STILL OCCURRING. THE PATIENT'S STOOL WAS THEN TESTED AND IT WAS DISCOVERED THAT THE PATIENT HAD C. DIFF. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION. ACCORDING TO THE CUSTOMER, THIS PATIENT WAS THE FIRST PERSON TO HAVE A PROCEDURE PERFORMED WITH THE SUBJECT COLONOSCOPE AFTER THE SCOPE WAS RETURNED FROM REPAIR. THE CUSTOMER CONFIRMED THAT THE COLONOSCOPE WAS REPROCESSED AS SOON AS IT WAS RETURNED FROM REPAIR. THE CUSTOMER CONFIRMED THAT THERE WAS NO SERIOUS INJURY, DEATH OR DELAYS DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ISSUES. AS OF (B)(6) 2019, THE INFECTION WAS RESOLVING AND THE PATIENT WAS SCHEDULED FOR A FOLLOW UP VISIT FOR THE FOLLOWING MONTH. THIS SCOPE WAS USED IN 37 ADDITIONAL COLONOSCOPY PROCEDURES SINCE THE REPAIR AND THERE WERE NO SIMILAR ISSUES REPORTED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 FUJIFILM MEDICAL SYSTEMS U.S.A., INC (FMSU) WAS NOTIFIED BY (B)(6) THAT ONE (1) PATIENT WAS REPORTED TO HAVE DEVELOPED AN INFECTION, C. DIFF (CLOSTRIDIOIDES DIFFICILE), AFTER A COLONOSCOPY PROCEDURE WITH A FUJIFILM COLONOSCOPE. THE CUSTOMER INDICATED TO FMSU THAT THEY WANTED TO ELIMINATE THE COLONOSCOPE AS A POSSIBLE CAUSE OF THE INFECTION. THE PROCEDURE WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT MENTIONED TO THE CUSTOMER THAT THEY HAD DIARRHEA IMMEDIATELY AFTER THE PROCEDURE AND IT WAS STILL OCCURRING. THE PATIENT'S STOOL WAS THEN TESTED AND IT WAS DISCOVERED THAT THE PATIENT HAD C. DIFF. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION. ACCORDING TO THE CUSTOMER, THIS PATIENT WAS THE FIRST PERSON TO HAVE A PROCEDURE PERFORMED WITH THE SUBJECT COLONOSCOPE AFTER THE SCOPE WAS RETURNED FROM REPAIR. THE CUSTOMER CONFIRMED THAT THE COLONOSCOPE WAS REPROCESSED AS SOON AS IT WAS RETURNED FROM REPAIR. THE CUSTOMER CONFIRMED THAT THERE WAS NO SERIOUS INJURY, DEATH OR DELAYS DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ISSUES. AS OF (B)(6) 2019, THE INFECTION WAS RESOLVING AND THE PATIENT WAS SCHEDULED FOR A FOLLOW UP VISIT FOR THE FOLLOWING MONTH. THIS SCOPE WAS USED IN 37 ADDITIONAL COLONOSCOPY PROCEDURES SINCE THE REPAIR AND THERE WERE NO SIMILAR ISSUES REPORTED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974757 FUJIFILM COLONOSCOPE EC-530LS2 COLONOSCOPE FDF FUJIFILM CORPORATION EC-530LS2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention