BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-612

    MDR report key: 23066083 · Received September 16, 2025

    Report

    Report Number
    9614641-2025-01551
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    May 29, 2025
    Report Date
    September 16, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1/INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). SINCE THE LITERATURE DESCRIBED "IT-KNIFE NANO", OLYMPUS SELECTED "KD-612Q" AS THE REPRESENTATIVE MODEL. 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. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PLANNED USE OF A NOVEL ELASTIC TRACTION DEVICE IMPROVES EFFICIENCY IN COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A PROPENSITY-SCORE MATCHED STUDY". BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR COLORECTAL LESIONS IS MORE CHALLENGING THAN FOR OTHER SITES, LEADING TO THE COMMON USE OF TRACTION DEVICES TO IMPROVE SUBMUCOSAL VISIBILITY AND ENDOSCOPE MANEUVERABILITY. THIS STUDY EVALUATED THE OUTCOMES AND EFFICIENCY OF A NOVEL ELASTIC TRACTION DEVICE (ETD), A ROTATABLE AND REOPENABLE DEVICE, IN COLORECTAL ESD. METHODS: WE RETROSPECTIVELY ANALYZED LESIONS (20¿50 MM) RESECTED AT SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER FROM JULY 2022 TO JANUARY 2024. LESIONS WERE DIVIDED INTO THE CONVENTIONAL ESD GROUP (C-ESD) AND THE ETD GROUP (T-ESD); THE T-ESD GROUP WAS FURTHER SPLIT INTO THE SCHEDULE (S) GROUP, WHERE ETD WAS PLANNED EARLY, AND THE RESCUE (R) GROUP, WHERE CONTINUED TREATMENT WAS DIFFICULT. PROPENSITY SCORE MATCHING (PSM) WAS USED TO BALANCE BASELINE FACTORS. RESULTS: OF 260 LESIONS, 136 WERE IN THE C-ESD GROUP AND 124 IN THE T-ESD GROUP. AFTER PSM, 101 LESIONS FROM EACH GROUP WERE ANALYZED. NO SIGNIFICANT DIFFERENCE WAS OBSERVED IN PROCEDURE TIME (47.13 ± 36.86 VS. 52.96 ± 39.17 MIN, P = 0.27) OR DISSECTION SPEED (33.54 ± 21.38 VS. 28.38 ± 18.81 MM2/MIN, P = 0.07). PERFORATION RATES WERE SIMILAR (4.0% VS. 5.9%, P = 0.51). IN THE S AND R GROUPS (58 AND 33 LESIONS, RESPECTIVELY), PROCEDURE TIME WAS SHORTER IN THE S GROUP (43.93 VS. 70.30 MIN, P < 0.01) WITH FASTER DISSECTION (35.80 VS. 20.23 MM2/MIN, P < 0.0001). POST-ETD ATTACHMENT, DISSECTION SPEED IMPROVED SIGNIFICANTLY (P < 0.001). CONCLUSIONS: ALTHOUGH THE ETD DID NOT CONSISTENTLY REDUCE PROCEDURE TIME OR IMPROVE DISSECTION SPEED, ITS PLANNED AND EARLY APPLICATION MAY OFFER POTENTIAL BENEFITS. FURTHER PROSPECTIVE MULTICENTER STUDIES ARE NEEDED TO CLARIFY ITS OPTIMAL ROLE AND CLINICAL VALUE IN COLORECTAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: MUSCLE LAYER DAMAGE (18 PATIENTS). PERFORATION (12 PATIENTS). DELAYED BLEEDING (1 PATIENT). THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659567 SINGLE USE ELECTROSURGICAL KNIFE KD-612 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-612Q NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ELASTIC TRACTION DEVICE (ETC, MICRO-TECH)| KD-655Q SINGLE USE ELECTROSURGICAL KNIFE| PCF-H290ZI EVIS LUCERA ELITE COLONOVIDEOSCOPE| SURECLIP (MICRO-TECH)| TECHNIFE (MICRO-TECH)| TRANSPARENT ATTACHMENT (TOP CORPORATION)| VIO3 (ERBE)