BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 20777621 · Received November 26, 2024

    Report

    Report Number
    9610595-2024-40195
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    May 13, 2024
    Report Date
    January 10, 2025
    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

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER'S INVESTIGATION. UPDATED FIELDS: D8, H6. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿LOW-POWER PURE-CUT HOT SNARE POLYPECTOMY FOR COLORECTAL POLYPS 10-14 MM IN SIZE: A MULTICENTER RETROSPECTIVE STUDY¿. BACKGROUND AND AIM: HOT SNARE EXCISION USING ELECTROCAUTERY IS WIDELY USED FOR LARGE COLORECTAL POLYPS (>10 MM); HOWEVER, ADVERSE EVENTS OCCUR DUE TO DEEP THERMAL INJURY. COLORECTAL POLYPS MEASURING 10¿14 MM RARELY INCLUDE INVASIVE CANCER. THEREFORE, LESS INVASIVE THERAPEUTIC OPTIONS FOR THIS SIZE CATEGORY ARE DEMANDING. WE HAVE DEVELOPED HOT SNARE POLYPECTOMY WITH LOW-POWER PURE-CUT CURRENT (LPPC HSP), WHICH IS EXPECTED TO CONTRIBUTE TO LESS DEEP THERMAL DAMAGE AND LOWER RISK OF ADVERSE EVENTS. THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF LPPC HSP FOR 10¿14 MM COLORECTAL POLYPS, COMPARED WITH CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (EMR). METHODS: IN THIS MULTICENTER, RETROSPECTIVE, OBSERVATIONAL STUDY, CLINICAL OUTCOMES OF EMR AND LPPC HSP FOR 10¿14 MM NONPEDUNCULATED COLORECTAL POLYPS BETWEEN JANUARY 2021 AND MARCH 2022 WERE COMPARED USING PROPENSITY SCORE MATCHING. RESULTS: WE IDENTIFIED (B)(4). AFTER PROPENSITY SCORE MATCHING, THE BASELINE CHARACTERISTICS BETWEEN THE GROUPS WERE COMPARABLE, WITH (B)(4) PAIRS. THE EN BLOC AND R0 RESECTION RATES WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN EMR AND LPPC HSP GROUPS (95.8% VS 97.5%, P = 0.72; 90.0% VS 91.7%, P = 0.82). IMMEDIATE BLEEDING, DELAYED BLEEDING, AND PERFORATION RATE DID NOT DIFFER BETWEEN THE TWO GROUPS (5/8% VS 2.5%, P = 0.33, 0% VS 0.8% P = 1.00, 0% VS 0%). CONCLUSIONS: COMPARED WITH CONVENTIONAL EMR, LPPC HSP SHOWED A SIMILAR RESECTION ABILITY WITHOUT AN INCREASE IN ADVERSE EVENTS. THESE RESULTS SUGGEST THAT LPPC HSP IS A SAFE AND EFFECTIVE TREATMENT FOR 10¿14 MM NONPEDUNCULATED COLORECTAL POLYPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: - IMMEDIATE BLEEDING (B)(4). - DELAYED BLEEDING: (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221474 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R COLONOSCOPE CF-EZ1500DI| COLONOSCOPE CF-HQ290ZI| COLONOSCOPE CF-XZ1200I| COLONOSCOPE EC-L600Z (FUJIFILM)| DISTAL ATTACHMENT MAJ-1990| ENDOSCOPIC MEASUREMENT DEVICE M2-3U| GENERATOR ESG-300 (WA90003W)| SNAREMASTER PLUS SD-400U-10