BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 14219223 · Received April 27, 2022

    Report

    Report Number
    8010047-2022-07113
    Event Type
    Death
    Date Received
    April 27, 2022
    Report Date
    June 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR. NEW INFORMATION ADDED TO B5. CORRECTION TO B1: BASED ON THE AUTHOR'S RESPONSE, THE EVENT HAS BEEN DETERMINED NOT REPORTABLE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "CRITICALLY-ILL PATIENTS WITH BILIARY OBSTRUCTION AND CHOLANGITIS: BEDSIDE FLUOROSCOPIC-FREE ENDOSCOPIC DRAINAGE VERSUS PERCUTANEOUS DRAINAGE." ABSTRACT: SEVERE ACUTE CHOLANGITIS IS A LIFE-THREATENING MEDICAL EMERGENCY. ENDOSCOPIC BILIARY DRAINAGE (EBD) OR PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) IS USUALLY USED FOR BILIARY DECOMPRESSION. HOWEVER, IT CAN BE RISKY TO TRANSPORT A CRITICAL PATIENT TO THE RADIOLOGY UNIT. WE AIMED TO COMPARE CLINICAL OUTCOMES BETWEEN BEDSIDE, RADIATION-FREE EBD AND FLUOROSCOPIC-GUIDED PTBD IN PATIENTS UNDER CRITICAL CARE. METHODS: A RETROSPECTIVE STUDY WAS CONDUCTED ON CRITICALLY ILL PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT WITH BILIARY OBSTRUCTION AND CHOLANGITIS FROM JANUARY 2011 TO APRIL 2020. RESULTS: A TOTAL OF 16 PATIENTS RECEIVING EBD AND 31 PATIENTS RECEIVING PTBD DUE TO SEVERE ACUTE CHOLANGITIS WERE ANALYZED. IN THE EBD GROUP, BILIARY DRAINAGE WAS SUCCESSFULLY CONDUCTED IN 15 (93.8%) PATIENTS. ONLY ONE PATIENT (6.25%) ENCOUNTERED POST-PROCEDURE PANCREATITIS. THE 30-DAY MORTALITY RATE WAS NO DIFFERENCE BETWEEN THE 2 GROUPS (32.72% VS. 31.25%, P = 0.96). BASED ON MULTIVARIATE ANALYSIS, INDEPENDENT PROGNOSTIC FACTORS FOR THE 30-DAY MORTALITY WERE A MEDICAL HISTORY OF MALIGNANCY OTHER THAN PANCREATOBILIARY ORIGIN (HR: 5.27, 95% CONFIDENCE INTERVAL [CI]: 1.01¿27.57) AND EMERGENT DIALYSIS (HR: 7.30, 95% CI: 2.20¿24.24). CONCLUSIONS: BEDSIDE EBD IS SAFE AND AS EFFECTIVE AS PERCUTANEOUS DRAINAGE IN CRITICALLY ILL PATIENTS. IT PROVIDES LOWER RISKS IN PATIENT TRANSPORTATION BUT DOES REQUIRE EXPERIENCED ENDOSCOPISTS TO PERFORM THE PROCEDURE. . IN OUR HOSPITAL, THE PERCUTANEOUS TRANS-HEPATIC BILIARY DRAINAGE (PTBD) WAS TYPICALLY USED FOR BILIARY DECOMPRESSION. SOME PATIENTS RECEIVED BEDSIDE EBD IN THE ICU WITHOUT FLUOROSCOPY DUE TO VARIOUS CONTRAINDICATIONS FOR PTBD INSERTION. ADVERSE EVENTS: N=1: MILD PANCREATITIS. N=5: DEATH AFTER PROCEDURE WITH OLYMPUS DEVICE. BASED ON MULTIVARIATE ANALYSIS, INDEPENDENT PROGNOSTIC FACTORS FOR THE 30-DAY MORTALITY WERE A MEDICAL HISTORY OF MALIGNANCY OTHER THAN PANCREATOBILIARY ORIGIN (HR: 5.27, 95% CONFIDENCE INTERVAL [CI]: 1.01¿27.57) AND EMERGENT DIALYSIS (HR: 7.30, 95% CI: 2.20¿24.24). CONCLUSIONS: BEDSIDE EBD IS SAFE AND AS EFFECTIVE AS PERCUTANEOUS DRAINAGE IN CRITICALLY ILL PATIENTS. THIS ARTICLE INCLUDES 2 REPORTS AS FOLLOWS: (B)(6): SINCE THE LITERATURE DESCRIBED "TJF-260", WE SELECTED "TJF-260V" AS A REPRESENTATIVE PRODUCT; ADVERSE EVENT. (B)(6): SINCE THE LITERATURE DESCRIBED "TJF-260", WE SELECTED "TJF-260V" AS A REPRESENTATIVE PRODUCT; DEATHS THIS IS REPORT 2 OF 2 FOR (B)(6): SINCE THE LITERATURE DESCRIBED "TJF-260", WE SELECTED "TJF-260V" AS A REPRESENTATIVE PRODUCT; DEATHS.

    Description of Event or Problem · 0

    THE AUTHOR PROVIDED ADDITIONAL INFORMATION AND REPORTED THERE WAS NO RELATIONSHIP BETWEEN THE OLYMPUS DEVICE AND THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841656 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death