BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    MDR report key: 14376697 · Received May 12, 2022

    Report

    Report Number
    8010047-2022-08145
    Event Type
    Death
    Date Received
    May 12, 2022
    Date of Event
    January 20, 2022
    Report Date
    June 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE, "THE IMPACT OF THE AGE-ADJUSTED CHARLSON COMORBIDITY INDEX AS A PROGNOSTIC FACTOR FOR ENDOSCOPIC PAPILLECTOMY IN AMPULLARY TUMORS." LITERATURE SUMMARY: BACKGROUND THE PROGNOSTIC NUTRITIONAL INDEX (PNI) AND CHARLSON COMORBIDITY INDEX (CCI) HAVE BEEN USEFUL FOR PREDICTING THE PROGNOSIS BASED ON NUTRITIONAL CONDITION AND COMORBIDITIES IN SURGERY AND ENDOSCOPIC MUCOSAL DISSECTION. THE AGE-ADJUSTED CCI (ACCI) HAS ALSO BEEN REPORTED TO BE USEFUL IN SURGERY, BUT IT HAS NOT BEEN APPLIED TO ENDOSCOPIC TREATMENT. WE THEREFORE CLARIFIED THE PROGNOSTIC FACTORS ASSOCIATED WITH AMPULLARY TUMORS TREATED WITH ENDOSCOPIC PAPILLECTOMY (EP). METHODS FROM JANUARY 2003 TO DECEMBER 2020, 236 PATIENTS WHO UNDERWENT EP FOR SPORADIC AMPULLARY TUMORS AT NAGOYA UNIVERSITY HOSPITAL WERE INCLUDED IN THIS STUDY. THE 5-YEAR SURVIVAL AND ABILITY TO PREDICT THE PROGNOSIS WERE EVALUATED IN TERMS OF THE SEX, PNI, ACCI, FINAL PATHOLOGICAL DIAGNOSIS, AND INTRADUCTAL EXTENSION. RESULTS DURING A MEDIAN FOLLOW-UP PERIOD OF 1558 DAYS, 17 PATIENTS DIED. NO PATIENT DIED OF THE PRIMARY DISEASE. THE 5-YEAR SURVIVAL RATE WAS 91.1%. IN A UNIVARIATE ANALYSIS, ONLY A HIGH ACCI (> 5) WAS EXTRACTED AS A SIGNIFICANT PROGNOSTIC FACTOR (ODDS RATIO, 12.2; 95% CONFIDENCE INTERVAL, 3.81-39.3; P < 0.001). THE 5-YEAR SURVIVAL RATES FOR A LOW ACCI (< 4) AND HIGH ACCI WERE 96.6% AND 73.5%, RESPECTIVELY (P < 0.001). CONCLUSIONS A HIGH ACCI IS AN IMPORTANT PROGNOSTIC FACTOR ASSOCIATED WITH THE 5-YEAR SURVIVAL AND A RISK OF DEATH FROM OTHER ILLNESS. AMPULLARY TUMORS SUITABLE FOR EP ARE LESS LIKELY TO BE A PROGNOSTIC FACTOR, AND TREATMENT-FREE FOLLOW-UP MAY BE ACCEPTABLE IN PATIENTS WITH A HIGH ACCI.  THE FOLLOWING ADVERSE EVENTS WERE REPORTED BY THE AUTHOR: PANCREATITIS, POSTOPERATIVE BLEEDING, PERFORATION, RECURRENCE. UPON PURSUIT OF ADDITIONAL INFORMATION, THE AUTHOR REPORTED NO ASSOCIATION BETWEEN THE OLYMPUS DEVICES AND ADVERSE EVENTS.   THE FOLLOWING DEATHS WERE REPORTED: NUMBER OF PATIENTS/CAUSE OF DEATH NOTED. DEATHS - DURING FOLLOW-UP: 1 AMPULLARY TUMOR; 2 WERE TREATMENT RELATED: 1 SEVERE PANCREATITIS AND 1 DUE TO COMPLICATIONS AFTER PANCREATICODUODENECTOMY; 8 OTHER ORGAN MALIGNANCIES; 3 PNEUMONIA; 1 CARDIAC DISEASE; 1 RENAL FAILURE; 1 SUBARACHNOID HEMORRHAGE; 1 SUDDEN DEATH. NO PATIENT DIED OF THE PRIMARY DISEASE. DEATHS - IN ENDOSCOPIC TREATMENT: 15 DUE TO OTHER ORGAN MALIGNANCY; 1 DUE TO SEVERE PANCREATITIS. DEATHS - ADDITIONAL SURGERY GROUP: 1 DUE TO POSTOP COMPLICATIONS. THERE ARE 2 REPORTS FOR THIS ARTICLE: PATIENT IDENTIFIER (B)(6) TJF-Q290V: PATIENT DEATHS; PATIENT IDENTIFIER (B)(6) SD-Y0001-U15: PATIENT DEATHS. THIS IS REPORT 1 OF 2 FOR PATIENT IDENTIFIER (B)(6) - TJF-Q290V: PATIENT DEATHS; SINCE THE LITERATURE DESCRIBED "TJF 290 V", WE SELECTED "TJF-Q290V" AS A REPRESENTATIVE PRODUCT FOR TJF-290V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041158 EVIS LUCERA ELITE DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q290V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death OLYMPUS SNARE, UNKNOWN LOT.