BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DUODENOSCOPE

    MDR report key: 10692890 · Received October 16, 2020

    Report

    Report Number
    1000513161-2020-00004
    Event Type
    Death
    Date Received
    October 16, 2020
    Report Date
    November 9, 2020
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION IS BEING PROVIDED IN SECTION B5 (PATIENT INFORMATION, STATUS OF PATIENT #2, TYPE OF PROCEDURE AND INDICATIONS FOR PROCEDURE), B7. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

    ON SEPTEMBER 22, 2020 FUJIFILM CORPORATION WAS INFORMED THAT A PATIENT AT A MEDICAL FACILITY IN THE UNITED KINGDOM (UK) DIED AFTER A PROCEDURE WITH A FUJIFILM SCOPE; FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS NOTIFIED ON (B)(6)2020. ADDITIONAL FOLLOW UP REVEALED THAT A SECOND PATIENT DIED AS WELL. THE PATIENTS UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR JAUNDICE. THE PATIENTS HAD PANCREATIC CANCER AND RECEIVED INTRAVENOUS ANTIBIOTICS ONCE THEY TESTED POSITIVE FOR INFECTION; THE COMMON LINK WAS DETERMINED TO BE A FUJIFILM SCOPE. THE HOSPITAL SUSPENDED ALL THREE FUJIFILM ED-530XT8 DUODENOSCOPES FOR FURTHER INVESTIGATION AND REMOVED FROM SERVICE AND SWABBED. PSEUDOMONAS WAS FOUND TO BE PRESENT ON THE DISTAL END OF THE SUBJECT SCOPE. TIMELINE: PATIENT 1 - (B)(6)2019 - ERCP PROCEDURE FOR JAUNDICE. (B)(6)2019 - SIGNS OF SEPSIS NOTED, PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS. (B)(6)2019 - PATIENT HAD MULTI-ORGAN FAILURE AND DIED. PATIENT 2 - (B)(6)2020 - ERCP PROCEDURE FOR OBSTRUCTIVE JAUNDICE. (B)(6)2020 - PSEUDOMONAS INFECTION DETECTED, PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS. (B)(6)2020 - PATIENT DIED. (B)(6)2020 (SPECIFIC DAY UNKNOWN) - THE FACILITY REQUESTED INSPECTION OF THE SUBJECT SCOPE (AT THAT TIME, INFORMATION ON PATIENT HEALTH HAZARDS WAS NOT PROVIDED TO LOCAL SERVICE). (B)(6)2020 - THE SUBJECT SCOPE WAS RECEIVED AT THE DISTRIBUTOR SERVICE FACILITY IN VERY POOR CONDITION. (B)(6)2020 - THE SUBJECT SCOPE WAS REPAIRED AND RETURNED TO THE FACILITY. THE REPAIRED SCOPE TESTED NEGATIVE. (B)(6)2020 (SPECIFIC DAY UNKNOWN) - THE INCIDENT REPORT WAS SUBMITTED TO THE MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) BY THE CUSTOMER. (B)(6)2020 - THE MHRA CONTACTED THE FUJIFILM LOCAL SUBSIDIARY FUJIFILM EUROPE GMBH, AND ON THE SAME DAY THE LOCAL SUBSIDIARY CONTACTED FUJIFILM CORPORATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: UNKNOWN. INITIAL REPORTER WAS THE (B)(6). INITIAL REPORTER INFORMATION: UNKNOWN. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    ON SEPTEMBER 22, 2020 FUJIFILM CORPORATION WAS INFORMED THAT A PATIENT AT A MEDICAL FACILITY IN (B)(6) DIED AFTER A PROCEDURE WITH A FUJIFILM SCOPE; FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS NOTIFIED ON (B)(6) 2020. THE DECEASED PATIENT TESTED POSITIVE FOR PSEUDOMONAS, THE SAME STRAIN WAS ALSO FOUND IN A SECOND PATIENT; THE COMMON LINK WAS DETERMINED TO BE A FUJIFILM SCOPE. THE SCOPE WAS REMOVED FROM SERVICE AND SWABBED. PSEUDOMONAS WAS FOUND TO BE PRESENT ON THE DISTAL END OF THE SCOPE. TIMELINE: (DATE UNKNOWN) - INFECTION OCCURRED IN PATIENTS (2 PATIENTS) (DATE UNKNOWN) - ONE PATIENT DIED. OUTCOME OF ANOTHER 1 PATIENT IS UNKNOWN. (DATE UNKNOWN) - THE SUBJECT SCOPE TESTED POSITIVE AT THE CUSTOMER FACILITY. (B)(6) 2020 (SPECIFIC DAY UNKNOWN) - THE FACILITY REQUESTED INSPECTION OF THE SUBJECT SCOPE (AT THAT TIME, INFORMATION ON PATIENT HEALTH HAZARDS WAS NOT PROVIDED TO LOCAL SERVICE). (DATE UNKNOWN) - THE SUBJECT SCOPE WAS RETURNED TO THE FACILITY. THE REPAIRED SCOPE TESTED NEGATIVE. SEPTEMBER 2020 (SPECIFIC DAY UNKNOWN) - THE INCIDENT REPORT WAS SUBMITTED TO THE (B)(6) BY THE CUSTOMER. SEPTEMBER 22, 2020 - THE (B)(6) CONTACTED THE FUJIFILM LOCAL SUBSIDIARY FUJIFILM (B)(4), AND ON THE SAME DAY THE LOCAL SUBSIDIARY CONTACTED FUJIFILM CORPORATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154804 FUJIFILM DUODENOSCOPE ENDOSCOPE FDT FUJIFILM CORPORATION ED-530XT8 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death