BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 10910221 · Received November 26, 2020

    Report

    Report Number
    8010047-2020-09499
    Event Type
    Death
    Date Received
    November 26, 2020
    Report Date
    November 26, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON NOVEMBER 12, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED ""ORIGINAL ARTICLE LEVEL OF TOTAL BILIRUBIN IN THE BILE OF THE FUTURE REMNANT LIVER OF PATIENTS WITH OBSTRUCTIVE JAUNDICE UNDERGOING HEPATECTOMY PREDICTS POSTOPERATIVE LIVER FAILURE"". THE PURPOSE OF THE LITERATURE WAS TO INVESTIGATE WHETHER THE DAILY LEVEL OF TOTAL BILIRUBIN IN THE BILE (LTB) EXCRETED FROM THE FUTURE REMNANT LIVER (FRL) CAN PREDICT POST-HEPATECTOMY LIVER FAILURE (PHLF) IN PATIENTS WITH OBSTRUCTIVE JAUNDICE UNDERGOING HEPATECTOMY. SEVENTY-FOUR PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA (N = 58) OR GALLBLADDER CANCER (N = 16) WERE INCLUDED. ALL PATIENTS UNDERWENT RIGHT HEPATECTOMY OR RIGHT TRISECTIONECTOMY OR LEFT TRISECTIONECTOMY AND/OR CAUDATE LOBECTOMY WITH BILE DUCT RESECTION AFTER BILIARY DRAINAGE AT OUR INSTITUTE BETWEEN 1994 AND 2016 AT TOKYO WOMEN'S MEDICAL UNIVERSITY. IN THE LITERATURE, IT WAS REPORTED THAT 5 POSTOPERATIVE INFECTIONS AFTER BILIARY DRAINAGE AND COLLECTION OF BILE JUICE FROM THE FRL AND RIGHT HEPATECTOMY OR RIGHT/LEFT TRISECTIONECTOMY WITH BILE DUCT RESECTION WAS OBSERVED. THESE FIVE PATIENTS ALSO HAD PHLF, THREE OF FIVE PATIENT DIED OF PHLF AND THE OTHER TWO DISCHARGED. THE PROCEDURE OF BILIARY DRAINAGE AND COLLECTION OF BILE JUICE FROM THE FRL WAS PERFORMED USING AN ENDOSCOPY (OLYMPUS; JF-260V, TJF-240, OR JF-240). IT WAS NOT FOUND WHAT THE MODEL NUMBER OF THE ENDOSCOPY THE SURGEON USED EACH OTHER. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, OMSC ASSUMED THAT 5 INFECTIONS MIGHT BE ASSOCIATED WITH THE DUODENOVIDEOSCOPE. THEREFORE, OMSC WILL SUBMIT 5 MEDICAL DEVICE REPORTS (MDR) FOR 5 POSTOPERATIVE INFECTIONS OF THE DUODENOVIDEOSCOPE. THIS REPORT IS 4 OF 5 REPORTS FOR 5 POSTOPERATIVE INFECTIONS OF THE DUODENOVIDEOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373527 DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death