BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 19968422 · Received August 12, 2024

    Report

    Report Number
    9610595-2024-16118
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    January 6, 2024
    Report Date
    August 29, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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, A 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    A2: THE MEAN PATIENT AGE WAS 65.6. OLYMPUS SELECTED "PCF-Q260JI" AS A REPRESENTATIVE PRODUCT. THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THE DEVICE WAS NOT RETURNED. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES IN COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE PROTRUDED LESIONS: A RETROSPECTIVE MULTICENTER STUDY." LITERATURE SUMMARY: BACKGROUND AND STUDY AIMS: COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IS INCREASINGLY USED FOR TREATING EARLY STAGE COLORECTAL CANCER, INCLUDING LARGE, PROTRUDED LESIONS (LPL). HOWEVER, THE CHALLENGES POSED BY LPLS, ESPECIALLY THOSE ACCOMPANIED BY SEVERE FIBROSIS OR MUSCLE-RETRACTING SIGNS (MRS), REMAIN UNCLEAR. THIS STUDY AIS TO INVESTIGATE ESD OUTCOMES FOR LPL , FOCUSING ON FACTORS SUCH AS TUMOR SIZE, AND SUBMUCOSAL FIBROSIS. PATIENTS AND METHODS IN A MULTICENTER RETROSPECTIVE STUDY (JUNE 2012 TO MAY 2023), DATA FROM 526 PATIENTS WITH 542 LPL LESIONS (>/- 2CM) WERE ANALYZED. PARAMETERS INCLUDED LESION SIZE, PROCEDURE TIME, DISSECTION SPEED, PHYSICIAN EXPERIENCE, SUBMUCOSAL FIBROSIS, AND ADVERSE EVENTS. THE TUNNEL METHOD, INCLUDING THE DOUBLE TUNNEL METHOD, WAS USED FOR CASES WITH SEVER FIBROSIS OR MRS. MULTIVARIATE ANALYSIS ASSESSED FACTORS AFFECTING PROCEDURE DIFFICULTY, PARTICULARLY LPLS >/- 4CM. RESULTS HE STUDY REVEALED AN IMPRESSIVE EN BLOC RESECTION RATE OF 97.8% AND A CURATIVE RESECTION RATE OF 78.6% FOR LPLS. NOTABLY, FIBROSIS AND MRS WERE PRESENT IN 25% AND 18% OF 4CM LPLS, RESPECTIVELY, AND THEIR FREQUENCY TENDED TO INCREASE AS THE TUMOR DIAMETER INCREASED. ONE TREATMENT STRATEGY FOR LPLS WAS THE TUNNELING METHOD, WHICH WAS USED MORE FREQUENTLY (41 CASES, 7.6%). FACTORS AFFECTING DISSECTION SPEED INCLUDED LARGER TUMOR SIZE, SUBMUCOSAL FIBROSIS, MRS AND PHYSICIAN EXPERIENCE. CONCLUSIONS TREATING LPLS THROUGH COLORECTAL ESD PRESENTS SIGNIFICANT CHALLENGES, ESPECIALLY IN PATIENTS WITH FIBROSIS AND MRS. THE STUDY HIGHLIGHTS THE IMPORTANCE OF RECOGNIZING THESE COMPLEXITIES, AND THAT MORE RELIABLE RESECTION STRATEGY MUST BE ESTABLISHED FOR ACCURATE PATHOLOGICAL EVALUATION THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE: DELAYED BLEEDING -12, INTRA PERFORATION -15, DELAYED PERFORATION -1 WHERE EMERGENCY SURGERY WAS REQUIRED POST-ESD COAGULATION SYNDROME -7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247416 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-Q260JI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GIF-H290T| KD-612L| KD-650L