BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM

    MDR report key: 7060130 · Received November 27, 2017

    Report

    Report Number
    2431293-2017-00080
    Event Type
    Death
    Date Received
    November 27, 2017
    Date of Event
    November 12, 2015
    Report Date
    January 5, 2018
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    04547410330915
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2017 THE IMPORTER ((B)(4)) BECAME AWARE OF THE ALLEGED EVENT. THE NOTIFICATION INDICATED A POTENTIAL CLAIM AGAINST FUJIFILM, STEMMING FROM A DEATH ALLEGEDLY RELATED TO A FUJIFILM DUODENOSCOPE MODEL ED-530XT, USED DURING A PROCEDURE PERFORMED ON (B)(6) 2015, AT (B)(6). WE HAVE NOT YET BEEN ABLE TO CONFIRM, HOWEVER, WHETHER A FUJIFILM DUODENOSCOPE MODEL ED-530XT WAS EVEN USED DURING THE PROCEDURE. THE FIRM IS WAITING TO RECEIVE MEDICAL RECORDS OF THE PATIENT TO CONDUCT FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THIS SUPPLEMENT PERTAINS TO INITIAL MDRS 3001722928-2017-0001 AND 2431293-2017-0080. IN THE INITIAL REPORT, FUJIFILM NOTED THAT ITS INVESTIGATION INTO THE UNDERLYING EVENT, INCLUDING WHETHER THE EVENT INVOLVED A FUJIFILM ED-530XT, WAS UNDERWAY. SINCE THE INITIAL REPORT WAS FILED, FUJIFILM HAS EVALUATED THE MEDICAL RECORDS AND ITS INTERNAL SERVICE RECORDS ASSOCIATED WITH THE EVENT AND SUBJECT SCOPE AND HEREBY PROVIDES THE FOLLOWING INFORMATION (WHICH WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS FILED). MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED SEPSIS FOLLOWING A (B)(6) 2015 ERCP AND/OR (B)(6) 2015 PTC PLACEMENT PROCEDURE AND EXPIRED ON (B)(6) 2015. PHYSICIAN NOTES INDICATE THAT SEPSIS WAS LIKELY CAUSED BY CHOLANGITIS RELATED TO A PREVIOUSLY DIAGNOSED CHOLEDOCHOLITHIASIS (BILE DUCT STONES OR GALLSTONES IN THE BILE DUCT). TWO MONTHS PRIOR TO THE ERCP, PATIENT HAD REPEATED HOSPITALIZATIONS RELATED TO CHOLELITHIASIS WITH GALLBLADDER DISTENSION LEADING TO A LAPAROSCOPIC CHOLECYSTECTOMY. FOLLOWING THE CHOLECYSTECTOMY, MEDICAL RECORDS INDICATE THAT PATIENT HAD A RESIDUAL BILE DUCT STONE RESULTING IN A FILLING DEFECT WITHIN THE MID TO DISTAL COMMON BILE DUCT CONSISTENT WITH CHOLEDOCHOLITHIASIS. PATIENT WAS THEN TRANSFERRED/ADMITTED TO (B)(6) MEDICAL CENTER FOR ERCP GALLSTONE REMOVAL. AT (B)(6) MEDICAL CENTER, PATIENT HAD TWO ERCP PROCEDURES PERFORMED. THE FIRST ERCP PROCEDURE WAS PERFORMED ON (B)(6) 2015 AND A REPEAT PROCEDURE WAS PERFORMED ON (B)(6) 2015. PATIENT EXPIRED ON (B)(6) 2015. NOTE THAT THERE IS NO ALLEGATION RELATED TO THE (B)(6) 2015 ERCP (CULTURES WERE TAKEN PRIOR TO THE NOV. 12 PROCEDURE). PATIENT DEATH RECORDS INDICATE THAT THE PRINCIPAL DIAGNOSIS (CAUSE OF DEATH) INCLUDED "SEPSIS, UNSPECIFIED ORGANISM." SECONDARY DIAGNOSES INCLUDED SEVERE SEPSIS WITH SEPTIC SHOCK, ACUTE KIDNEY FAILURE, ACIDOSIS, OBSTRUCTION OF DUODENUM, CALCULUS OF BILE DUCT WITH CHOLANGITIS, OTHER SPECIFIED DISEASE OF LIVER, AND UNSPECIFIED ATRIAL FIBRILLATION. THIS MDR IS RELATED TO SUPPLEMENTAL MANUFACTURER MDR REPORT 3001722928-2017-00001. FUJIFILM WILL FURTHER SUPPLEMENT THIS MDR, AS NEEDED, SHOULD ANY NEW INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839230 FUJIFILM VIDEO ENDOSCOPE FDT FUJIFILM CORPORATION ED-530XT 04547410330915

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death