BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 24433581 · Received February 24, 2026

    Report

    Report Number
    9614641-2026-00230
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    September 15, 2025
    Report Date
    March 16, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿FEASIBILITY AND SAFETY OF ENDOSCOPIC RESECTION FOR CARDIAL SUBMUCOSAL TUMORS MORE THAN 30 MM IN DIAMETER¿. BACKGROUND OF THE STUDY ENDOSCOPIC RESECTION HAS EMERGED AS A VIABLE OPTION FOR CARDIAL SUBMUCOSAL TUMORS (SMTS), BUT EXISTING EVIDENCE REMAINS LIMITED BY SMALL SAMPLE SIZES. THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF ENDOSCOPIC RESECTION TECHNIQUES FOR CARDIAL SMTS MORE THAN 30 MM IN DIAMETER. METHODS BETWEEN (B)(6) 2012 AND (B)(6) 2024, 107 PATIENTS WITH CARDIAL SMTS LARGER THAN 30 MM WERE INCLUDED IN THIS STUDY. DATA ON PATIENT CHARACTERISTICS, CLINICAL OUTCOMES, AND FOLLOW-UP WERE RETROSPECTIVELY ANALYZED. RESULTS AMONG 107 PATIENTS, 42 PATIENTS UNDERWENT SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER), 34 PATIENTS UNDERWENT ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR), AND 31 PATIENTS RECEIVED ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE MEAN LESION SIZE WAS 4.2 ± 1.9 CM. THE RATE OF EN BLOC RESECTION AND COMPLETE RESECTION WERE 94.3% AND 91.6%, RESPECTIVELY. POSTOPERATIVE ADVERSE EVENTS INCLUDED DELAYED BLEEDING (2 CASES), DELAYED PERFORATION (2 CASES), SUBCUTANEOUS EMPHYSEMA (2 CASES) AND PLEURAL EFFUSION (2 CASES). ONE CASE OF RECURRENCE WAS DETECTED DURING THE MEAN FOLLOW-UP PERIOD OF 37.4 ± 22.5 MONTHS. MULTIVARIATE ANALYSIS SHOWED IRREGULAR MORPHOLOGY (OR 2.076, 95% CI 0.513¿6.274, P = 0.039) AND INVASION INTO THE MUSCULARIS PROPRIA LAYER (OR 6.157, 95% CI1.160¿7.602, P = 0.031) WERE INDEPENDENT RISK FACTORS FOR INCOMPLETE RESECTION; LESION SIZE = 40 MM (OR 6.271, 95% CI 1.024¿7.856, P = 0.027), IRREGULAR MORPHOLOGY (OR 4.734, 95% CI 1.489¿6.052, P = 0.042), TRANS-CARDIA TUMOR (OR 5.526, 95% CI 1.160¿7.602, P = 0.043) AND INVASION INTO THE MUSCULARIS PROPRIA LAYER (OR 5.104, 95% CI 1.893¿7.965, P = 0.030) WERE INDEPENDENT RISK FACTORS FOR LONG OPERATIVE TIMES. CONCLUSION ENDOSCOPIC RESECTION IS AN EFFECTIVE AND SAFE TREATMENT FOR CARDIAL SMTS LARGER THAN 30 MM, PARTICULARLY WHEN PERFORMED BY EXPERIENCED ENDOSCOPISTS. LONG-TERM SURVEILLANCE REMAINS CRUCIAL FOR EARLY DETECTION OF RECURRENCE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS DELAYED BLEEDING IN 2 PATIENTS DELAYED PERFORATION IN 2 PATIENTS SUBCUTANEOUS EMPHYSEMA IN 2 PATIENTS. PLEURAL EFFUSION IN 2 PATIENTS. THIS REPORT IS 1 OF 2 FOR THE ADVERSE EVENTS INCLUDED IN THE ARTICLE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486007 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-611L NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GIF-HQ290 GASTROINTESTINAL VIDEOSCOPE, SN -UNK| KD-620QR, ELECTROSURGICAL KNIFE, LOT-UNK