BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DUODENOSCOPE

    MDR report key: 10487862 · Received September 3, 2020

    Report

    Report Number
    3001722928-2020-00013
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 7, 2020
    Report Date
    October 16, 2020
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    14547410359289
    PMA / PMN Number
    K191747
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOSCOPE WAS RETURNED TO FUJIFILM MEDICAL SYSTEMS U.S.A., INC (FMSU) ON SEPTEMBER 11, 2020, AND THE INSPECTION WAS CONCLUDED ON SEPTEMBER 21, 2020. THE DEVICE SHOWED SOME WEAR INCLUDING A LEAK ALONG THE SEAM OF THE DISTAL COVER PLATE. THE LEAK, WHICH WAS NOT DETECTED BY THE CUSTOMER, MAY BE A POTENTIAL CONTRIBUTORY FACTOR HOWEVER CANNOT BE CONFIRMED. THE CAUSE OR PRESENCE OF MICROORGANISM COULD NOT BE DETERMINED. AS A PRECAUTION THE CUSTOMER IS INCREASING THE CULTURING TESTING FOR THEIR SCOPES FROM A MONTHLY BASIS TO TWICE A MONTH. ADDITIONALLY ON SEPTEMBER 29, 2020, A FUJIFILM CLINICAL SPECIALIST VISITED THE SUBJECT FACILITY TO OBSERVE THE CUSTOMER'S REPROCESSING PROCESS. THE SPECIALIST OBSERVED DEVIATIONS FROM THE RECOMMENDED INSTRUCTIONS FOR USE WHEN PERFORMING THE LEAK TEST AND MANUAL CLEANING ON A DIFFERENT MODEL SCOPE. FUJIFILM DETERMINED THAT IMPROPER REPROCESSING CONDUCTED AT THIS FACILITY MAY HAVE CONTRIBUTED TO THIS ISSUE. A RETRAINING WILL BE PERFORMED FOR THE FACILITY STAFF IN NOVEMBER 2020. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE ENDOSCOPE WAS REQUESTED FOR RETURN FOR INSTRUMENT INSPECTION/EVALUATION BY FUJIFILM MEDICAL SYSTEMS USA (FMSU). THE INVESTIGATION IS IN PROGRESS. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AUGUST 11, 2020 FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS INFORMED THAT A FUJIFILM DUODENOSCOPE TESTED POSITIVE FOR CRE (CARBAPENEM-RESISTANT ENTEROBACTERIACEAE) GROWTH; FUJIFILM CORPORATION RECEIVED THE NOTIFICATION OF THE EVENT ON AUGUST 11, 2020. THIS ISSUE WAS FOUND BY A PERIODIC CULTURING TEST PERFORMED AT THE FACILITY AFTER "SINK CLEANING" AND AFTER HIGH-LEVEL DISINFECTION; THE SCOPE WAS PLACED OUT OF SERVICE, THE COLONY-FORMING UNIT (CFU) WAS NOT PROVIDED. THE DUODENOSCOPE WAS RE-CULTURED TWICE AGAIN AND THERE WERE NO SIGNS OF GROWTH. THE CUSTOMER WAS UNSURE WHICH INSTANCE OF PATIENT USE RESULTED IN THE CONTAMINATION, HOWEVER THEY HAVE A LIST OF ALL PATIENTS THAT WERE TREATED WITH THE SCOPE. THE CUSTOMER VERIFIED THAT THERE WAS NO PATIENT IMPACT SUCH AS SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ON AUGUST 11, 2020 FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS INFORMED THAT A FUJIFILM DUODENOSCOPE TESTED POSITIVE FOR CRE (CARBAPENEM-RESISTANT ENTEROBACTERIACEAE) GROWTH; FUJIFILM CORPORATION RECEIVED THE NOTIFICATION OF THE EVENT ON AUGUST 11, 2020. THIS ISSUE WAS FOUND BY A PERIODIC CULTURING TEST PERFORMED AT THE FACILITY AFTER "SINK CLEANING" AND PRIOR TO HIGH-LEVEL DISINFECTION; THE SCOPE WAS PLACED OUT OF SERVICE, THE COLONY-FORMING UNIT (CFU) WAS NOT PROVIDED. THE DUODEONOSCOPE WAS RE-CULTURED TWICE AGAIN AND THERE WERE NO SIGNS OF GROWTH. THE CUSTOMER WAS UNSURE WHICH INSTANCE OF PATIENT USE RESULTED IN THE CONTAMINATION, HOWEVER THEY HAVE A LIST OF ALL PATIENTS THAT WERE TREATED WITH THE SCOPE. THE CUSTOMER VERIFIED THAT THERE WAS NO PATIENT IMPACT SUCH AS SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952009 FUJIFILM DUODENOSCOPE ENDOSCOPE FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1