BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 19609178 · Received June 25, 2024

    Report

    Report Number
    9614641-2024-01324
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 2, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170225963
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000313.

    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, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS 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.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE ARTICLE "QUANTIFICATION OF INTERSTITIAL CELLS OF CAJAL AND FIBROSIS DURING GASTRIC PER-ORAL ENDOSCOPIC MYOTOMY AND ITS ASSOCIATION WITH CLINICAL OUTCOMES." THIS WAS A PROSPECTIVE STUDY OF GASTROPARETIC PATIENTS WHO UNDERWENT G-POEM AND INTRAPROCEDURAL PYLORIC MUSCLE BIOPSIES BETWEEN JANUARY 2022 AND APRIL 2023. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS MUCOSOTOMY: 1 PATIENT. THIS WAS ADEQUATELY CLOSED ON THE MUCOSAL SIDE WITH PLACEMENT OF TWO HEMOSTATIC CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750856 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-611L 04953170225963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DISTAL ATTACHMENT, MH-588| EVIS EXERA GASTROINTESTINAL VIDEOSCOPE, GIF-H190