BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 19144411 · Received April 19, 2024

    Report

    Report Number
    9610595-2024-08281
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    November 16, 2023
    Report Date
    May 8, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170202339
    PMA / PMN Number
    K100584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 ADDITIONAL INFORMATION RECEIVED, FROM THE AUTHOR. B5 UPDATED ACCORDINGLY. ALSO, A CORRECTION HAS BEEN MADE TO G2 TO PROVIDE INFORMATION, THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "RECURRENCE RATE AFTER PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION OF <20 MM NON-PEDUNCULATED COLORECTAL LESIONS: SHOULD WE WORRY ABOUT THE RISK?". LITERATURE SUMMARY INTRODUCTION: THERE IS SCARCE DATA FOCUSED ON RECURRENCE NEOPLASIA RATE (RR) AFTER PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION (PEMR) OF 10¿19 MM NON-PEDUNCULATED COLORECTAL LESIONS (NPL). WE AIMED TO ANALYZE THE RR AFTER PEMR OF 10¿19 MM NPL, IDENTIFY RISK FACTORS FOR ITS DEVELOPMENT AND COMPARE IT WITH RR AFTER PEMR OF = 20 MM NPL. METHODS: RETROSPECTIVE COHORT-STUDY INCLUDING ALL =10 MM NPL RESECTED BY PEMR IN OUR CENTER BETWEEN 2018¿2022 WITH AN EARLY REPEAT COLONOSCOPY (ERC). RR WAS DEFINED AS RECURRENCE NEOPLASIA IDENTIFIED IN THE ERC EMR SCAR WITH VIRTUAL CHROMOENDOSCOPY OR HISTOLOGICAL CONFIRMATION. INTRAPROCEDURAL BLEEDING WAS DEFINED AS BLEEDING REQUIRING SPECIFIC ENDOSCOPIC TREATMENT DURING THE INDEX COLONOSCOPY. DEEP MURAL INJURY WAS CLASSIFIED ACCORDING TO THE SYDNEY CLASSIFICATION. RESULTS: A TOTAL OF 444 NPL WERE ASSESSED, 124 (27.9%) WITH 10¿19 MM. IN THE ERC, PERFORMED A MEDIAN OF 6 MONTHS AFTER PEMR, RR WAS SIGNIFICANTLY LOWER FOR 10¿19 MM NPL COMPARED TO = 20 MM NPL (13/124 VS 68/320, P = 0.005). IN SUBGROUP ANALYSIS, RR AFTER PEMR OF 15¿19 MM NPL WAS SIGNIFICANTLY HIGHER COMPARED TO 10¿14 MM NPL (13/98 VS 0, P = 0.041) BUT NOT SIGNIFICANTLY DIFFERENT COMPARED TO = 20 MM NPL (13/98 VS 68/320, P = 0.073). IN MULTIVARIABLE ANALYSIS, SIZE OF NPL (HR 1.501, 95% CI 1.012¿ 2.227, P = 0.044) WAS THE ONLY INDEPENDENT RISK FACTOR IDENTIFIED FOR RR FOR 10¿19 MM NPL. CONCLUSION: ALTHOUGH THE EARLY RR AFTER PEMR OF 10¿19 MM NPL IS SIGNIFICANTLY LOWER COMPARED TO = 20 MM NPL, IT IS NON-NEGLIGIBLE (10.5%) AND APPEARS TO BE THE HIGHEST AMONG 15¿19 MM NPL. THE SIZE OF THE LESION WAS THE ONLY INDEPENDENT RISK FACTOR FOR RR. OUR FINDINGS SHOULD BE ACCOUNTED IN THE SELECTION OF THE MOST APPROPRIATE POST-POLYPECTOMY ENDOSCOPIC SURVEILLANCE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS INTRAPROCEDURAL BLEEDING (45) DEEP MURAL INJURY (6 [TYPE 1-1, TYPE 2-3, TYPE 3-2]).

    Description of Event or Problem · 0

    ALTHOUGH, ADDITIONAL INFORMATION REGARDING, THE EVENTS DESCRIBED IN THE LITERATURE ARTICLE WERE REQUESTED. THE PHYSICIAN WAS UNABLE TO PROVIDE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082411 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H180AL 04953170202339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ERBE VIO 300S ELECTROSURGICAL SYSTEM| UNKNOWN CLIP| UNKNOWN SNARE