BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 16108498 · Received January 5, 2023

    Report

    Report Number
    9610595-2023-00244
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 7, 2022
    Report Date
    March 14, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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 DOI: 10.3390/BIOMEDICINES10123166 PROVIDED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO E4 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO H6 CODE (TYPE OF INVESTIGATION). CODE 4109 WAS INADVERTENTLY SELECTED ON THE PREVIOUS SUBMISSION. THIS CODE HAS BEEN CORRECTED TO 4114 (DEVICE NOT RETURNED).

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ACUTE KIDNEY INJURY AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY¿A HOSPITAL-BASED PROSPECTIVE OBSERVATIONAL STUDY". BACKGROUND: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) REPRESENTS A MAJOR PIVOTAL POINT IN GASTROINTESTINAL ENDOSCOPY. LITTLE IS KNOWN ABOUT ACUTE KIDNEY INJURY (AKI) POST-ERCP. THIS STUDY ANALYSES THE INCIDENCE, RISK FACTORS, AND PROGNOSIS OF POST-ERCP AKI. METHODS: A TOTAL OF 396 PATIENTS WERE PROSPECTIVELY STUDIED. AKI WAS DEFINED BY AN INCREASE IN SERUM CREATININE (SCR) = 0.3 MG/DL OR BY AN INCREASE IN SCR = 50% IN THE FIRST 48 H POST-ERCP. LOGISTIC REGRESSION ANALYSIS WAS USED TO IDENTIFY THE PREDICTORS OF AKI AND IN-HOSPITAL MORTALITY. A TWO-TAILED P VALUE < 0.05 WAS CONSIDERED SIGNIFICANT. RESULTS: ONE HUNDRED AND THREE PATIENTS (26%) DEVELOPED POST-ERCP AKI. ESTIMATED GLOMERULAR FILTRATION RATE (ADJUSTED ODDS RATIO (AOR) = 0.95, 95% CONFIDENCE INTERVAL (CI): 0.94¿0.96, P < 0.001), NONRENAL CHARLSON COMORBIDITY INDEX (AOR = 1.19, 95% CI: 1.05¿1.35, P = 0.006), CHOLEDOCHOLITHIASIS (AOR = 4.05, 95% CI: 1.98¿8.29, P < 0.001), AND BILIRUBIN (AOR = 1.1, 95% CI: 1.05¿1.15, P < 0.001) WERE ASSOCIATED WITH POST-ERCP AKI. POST-ERCP AKI WAS ASSOCIATED WITH LONGER HOSPITAL STAY (P < 0.001) AND WITH INCREASED IN-HOSPITAL MORTALITY (7.76% VERSUS 0.36%, P < 0.001). MODERATE-TO-SEVERE (STAGE 2 AND 3) AKI WAS INDEPENDENTLY ASSOCIATED WITH IN-HOSPITAL MORTALITY (AOR = 6.43, 95% CI: 1.48¿27.88, P < 0.013). CONCLUSIONS: POST-ERCP AKI REPRESENTED AN IMPORTANT COMPLICATION ASSOCIATED WITH LONGER HOSPITAL STAY. MODERATE-TO-SEVERE POST-ERCP AKI WAS AN INDEPENDENT RISK FACTOR FOR IN-HOSPITAL MORTALITY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PANCREATITIS - 14 PATIENTS. BLEEDING - 2 PATIENTS. PERFORATION - 2 PATIENTS. DEATH - 9 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): ADVERSE EVENTS. (B)(6): DEATHS. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507228 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other