BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 23927858 · Received December 30, 2025

    Report

    Report Number
    9614641-2025-02181
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 1, 2025
    Report Date
    January 20, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K250351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Additional Manufacturer Narrative · 0

    THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE AUTHOR. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: H6. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. 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 "COMPARATIVE EFFICACY AND SAFETY OF INJECTION MUCOSA KNIFE VERSUS CONVENTIONAL TECHNIQUES IN ENDOSCOPIC SUBMUCOSAL DISSECTION FOR RECTAL LATERALLY SPREADING TUMORS." BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IS A STANDARD TREATMENT FOR RECTAL LATERALLY SPREADING TUMORS (LSTS). THIS STUDY AIMS TO COMPARE THE EFFICACY AND SAFETY OF THE INJECTION MUCOSA KNIFE (IMK) TECHNIQUE VERSUS THE CONVENTIONAL DUAL KNIFE (DK) TECHNIQUE IN ESD FOR RECTAL LSTS. METHODS: A TOTAL OF 229 PATIENTS WITH RECTAL LSTS WERE ENROLLED FROM FOUR HOSPITALS BETWEEN JUNE 2020 AND JUNE 2025 AND WERE DIVIDED INTO TWO GROUPS: THE IMK GROUP (N = 108) AND THE DK GROUP (N = 121). THE PRIMARY OUTCOME MEASURES INCLUDED TOTAL PROCEDURE TIME, MUCOSAL DISSECTION TIME, AND SUBMUCOSAL DISSECTION RATE, WHILE THE SECONDARY OUTCOMES ENCOMPASSED INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS AS WELL AS THE R0 RESECTION RATE. ADDITIONALLY, THE EFFICACY AND SAFETY OF THE TWO GROUPS WERE COMPARED BASED ON TUMOR SIZE AND ENDOSCOPIC MORPHOLOGY. RESULTS: THE IMK GROUP DEMONSTRATED SIGNIFICANTLY SHORTER TOTAL PROCEDURE TIME (MEDIAN 50 VS. 65 MINS, P < 0.001) AND MUCOSAL DISSECTION TIME (MEDIAN 40 VS. 56 MINS, P < 0.001), ALONG WITH A HIGHER SUBMUCOSAL DISSECTION RATE (MEDIAN 0.12 VS. 0.08 CM²/MIN, P < 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES IN INTRAOPERATIVE PERFORATION, SEVERE HEMORRHAGE, R0 RESECTION, POSTOPERATIVE BLEEDING, FEVER, OR PATHOLOGY BETWEEN THE TWO GROUPS (P > 0.05). SUBGROUP ANALYSES BASED ON TUMOR SIZE (2.5 CM AND =2.5 CM) AND MORPHOLOGY (LST-G AND LST-NG) CONSISTENTLY SHOWED SUPERIOR EFFICIENCY OF THE IMK TECHNIQUE WITHOUT COMPROMISING SAFETY. CONCLUSIONS: THE IMK TECHNIQUE SIGNIFICANTLY IMPROVES THE EFFICIENCY OF ESD FOR RECTAL LSTS BY REDUCING OPERATIVE TIME AND ENHANCING DISSECTION RATES, WHILE MAINTAINING COMPARABLE SAFETY AND OUTCOMES TO THE CONVENTIONAL DK TECHNIQUE. IMK REPRESENTS A PROMISING ADVANCEMENT IN ESD FOR RECTAL LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. EVENT 1: INTRAOPERATIVE PERFORATION IN DK GROUP N=1. EVENT 2: SEVERE INTRAOPERATIVE HEMORRHAGE IN DK GROUP N=6. EVENT 3: SEVERE INTRAOPERATIVE HEMORRHAGE IN IMK GROUP N=3. EVENT 4: POSTOPERATIVE BLEEDING IN DK GROUP N=2. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836091 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-650L NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GIF-Q260J GASTROINTESTINAL VIDEOSCOPE.