BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DUODENOSCOPE ED-530XT8

    MDR report key: 11976304 · Received June 10, 2021

    Report

    Report Number
    3001722928-2021-00010
    Event Type
    Death
    Date Received
    June 10, 2021
    Date of Event
    January 10, 2020
    Report Date
    June 10, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    PMA / PMN Number
    K182051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION FROM THE HOSPITAL AND DISTRIBUTOR OBTAINED ON OCTOBER 20, 2020 LED TO THE CONCLUSION THAT THE HOSPITAL HAD NOT BEEN FOLLOWING THE REPROCESSING INSTRUCTIONS AS DESCRIBED IN THE CLEANING MANUAL. FUJIFILM FOUND THAT THE HOSPITAL NEVER PURCHASED THE FUJIFILM SPECIAL ACCESSORIES INTENDED FOR THE SUBJECT SCOPE AND THAT THE PATIENT SINGLE USE ACCESSORIES WERE REUSED. A FEW OF THE ACCESSORIES ARE UNIQUE AND SPECIALLY DESIGNED FOR THE ED-530XT8 AND ONLY AVAILABLE FROM FUJIFILM OR THEIR DISTRIBUTORS AND NOT AVAILABLE ON THE THIRD PARTY MARKET. FUJIFILM CONCLUSION: A COMBINATION OF NOT FOLLOWING THE INTENDED REPROCESSING METHOD, REUSE OF PATIENT SINGLE USE ACCESSORIES AND NOT MAINTAINING THE ENDOSCOPE ACCORDING TO THE INSTRUCTIONS HAS A HIGH POTENTIAL RISK OF CONTAMINATION SUCH AS TRANSFER OF PSEUDOMONAS FROM PATIENT TO PATIENT. THE HOSPITAL HAS BEEN SWAB TESTING ALL THREE ED-530XT8 DUODENOSCOPES ON A ROUTINE BASIS SINCE THIS ISSUE OCCURRED AND CONFIRMED THAT TO DATE NO PSEUDOMONAS HAVE BEEN DETECTED. THE HOSPITAL RECEIVED ADDITIONAL REPROCESSING TRAINING. FUJIFILM PREVIOUSLY SUBMITTED THIS INCIDENT IN 3001722928-2020-00016, WHICH REPORTED TWO INCIDENTS INVOLVING THE SAME FUJIFILM SCOPE RESULTING IN TWO PATIENT DEATHS. DURING A FUJIFILM INTERNAL REVIEW OF THEIR ADVERSE EVENT REPORTING PROCEDURE, IT WAS DETERMINED THAT SEPARATE MEDWATCH REPORTS WERE REQUIRED TO BE SUBMITTED FOR EACH PATIENT. THIS REPORT IS BEING SUBMITTED FOR THE 2ND PATIENT DEATH THAT WAS ORIGINALLY REPORTED IN 3001722928-2020-00016.

    Description of Event or Problem · 1

    ON SEPTEMBER 22, 2020, FUJIFILM CORPORATION WAS INFORMED THAT A PATIENT HAD TESTED POSITIVE FOR PSEUDOMONAS AFTER A PROCEDURE WITH A FUJIFILM ED-530XT8 SCOPE. FUJIFILM WAS LATER INFORMED THAT THE PATIENT HAD DIED. THE PATIENT UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR JAUNDICE. THE PATIENT HAD PANCREATIC CANCER AND RECEIVED INTRAVENOUS ANTIBIOTICS ONCE HE TESTED POSITIVE FOR INFECTION. THE SAME PSEUDOMONAS STRAIN WAS ALSO FOUND IN ANOTHER PATIENT THAT HAD ALSO DIED; THE COMMON LINK WAS DETERMINED TO BE THE ED-530XT8 SCOPE. THE HOSPITAL SUSPENDED ALL THREE ED-530XT8 DUODENOSCOPES FOR FURTHER INVESTIGATION, AND THE SCOPES WERE REMOVED FROM SERVICE AND SWABBED. PSEUDOMONAS WAS FOUND OT BE PRESENT ON THE DISTAL END OF THE SUBJECT SCOPE. TIMELINE: (B)(6) 2020 - ERCP PROCEDURE FOR OBSTRUCTIVE JAUNDICE. (B)(6) 2020 - PSEUDOMONAS INFECTION DETECTED, PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS. (B)(6) 2020 - PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870871 FUJIFILM DUODENOSCOPE ED-530XT8 DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-530XT8 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death