BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 16850255 · Received May 1, 2023

    Report

    Report Number
    9610595-2023-06950
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 11, 2021
    Report Date
    July 17, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    N/A
    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. 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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. 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 EVENTS 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "CURATIVE VALUE OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION FOR SUBMUCOSALLY INVASIVE COLORECTAL CANCER." THIS WAS A RETROSPECTIVE, OBSERVATIONAL STUDY EVALUATED THE FEASIBILITY OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) FOR PATHOLOGICALLY INVASIVE COLORECTAL CANCER (PT1-CRC). A TOTAL OF 31 PATIENTS WERE TREATED WITH UEMR AND 32 PATIENTS WERE TREATED WITH CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR). THE ENDOSCOPIC COMPLETE RESECTION RATE WAS 100%. TOTAL EN BLOC RESECTION WAS OBTAINED IN 77%, AND THE VM0, HM0, AND R0 RESECTION RATES WAS 81%, 58%, AND 55%. THE ENDOSCOPIC COMPLETE RESECTION RATE WAS 100% IN CEMR. CEMR SHOWED A SIMILAR EN BLOC (78%), VM0 (78%), HM0 (66%), AND R0 RESECTION RATES (63%). LYMPHO-VASCULAR INVOLVEMENT WAS OBSERVED IN SIX PATIENTS (18%), AND UNFAVORABLE FEATURES FOR LNM WERE SEEN IN 22 PATIENTS (68%) IN THE CEMR GROUP. REGARDING PT1A LESIONS (N = 6), THE VM0 AND CLINICALLY OR PATHOLOGICALLY CURATIVE RESECTION RATES IN CEMR WERE SIMILAR TO THOSE OF UEMR (100%, 67%, AND 100%). UEMR HAS A FEASIBLE VM0 RATE FOR RESECTING PT1-CRC¿ESPECIALLY FOR PT1A CRC¿WITHOUT CHARACTERISTICS OF DEEP SUBMUCOSAL INVASION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS UEMR COHORT: DELAYED BLEEDING - 2 PATIENTS. NO PERFORATION OR POST-ELECTROCOAGULATION SYNDROME OCCURRED AFTER EITHER PROCEDURE. ALL THESE ADVERSE EVENTS WERE CURABLE WITH CONSERVATIVE TREATMENT. THE EVENT DATE WAS REPORTED AS THE PUBLICATION DATE OF THE LITERATURE. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) IS FOR SCOPE MODEL PCF-Q260AZI. (B)(6) IS FOR SCOPE MODEL PCF-H290TI. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATED THAT SINCE THERE WERE MULTIPLE CASES, IT WAS NOT POSSIBLE TO "GRASP" WHICH CASE WAS WHICH. THE AUTHOR STATED THAT THERE WAS NO PROBLEM FROM THEIR PERSPECTIVE, AS COMPLICATIONS HAPPEN WITH ANY SCOPE AND TREATMENT; IT WAS NOT ISOLATED TO THE OLYMPUS PRODUCTS. THERE WERE NO MALFUNCTIONS AS FAR AS THE AUTHOR COULD REMEMBER. LOT/SERIAL INFORMATION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712200 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H290TI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention