BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 18188612 · Received November 21, 2023

    Report

    Report Number
    9614641-2023-01764
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 30, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170265761
    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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (D8). ADDITIONALLY, TO PROVIDE ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW-UP (B)(4). 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 EVENT 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.

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "DUALKNIFE", WE SELECTED "SINGLE USE ELECTROSURGICAL KNIFE KD-650" AS A REPRESENTATIVE PRODUCT. THE PRODUCT WAS UNKNOWN BUT A REPRESENTATIVE PRODUCT WAS CHOSEN FOR PROCESSING PURPOSES. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    THE AUTHOR CONFIRMED NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE. NO RESPONSE PROVIDE BY THE AUTHOR ON IF AN OLYMPUS DEVICE CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT ADVERSE EVENTS.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "CLINICAL RESULTS OF PROKNIFE AND DUAL KNIFE USAGE EXAMPLES IN GASTRIC ESD". IN THIS STUDY, THE PURPOSE WAS TO CLARIFY THE CLINICAL RESULTS OF GASTRIC ESD USING PROKNIFE AND SINGLE USE ELECTROSURGICAL KNIFE KD-650. OF THE 96 PATIENTS WHO UNDERWENT GASTRIC ESD AT OUR HOSPITAL FROM JANUARY 2022 TO SEPTEMBER 2022, WE RETROSPECTIVELY ANALYZED 57 PATIENTS USING PROKNIFE AS GROUP P AND 39 PATIENTS USING SINGLE USE ELECTROSURGICAL KNIFE KD-650 AS GROUP D. INTRAOPERATIVE PERFORATION WAS OBSERVED IN 7% OF GROUP P AND 0% OF GROUP D. POST-OPERATIVE BLEEDING WAS OBSERVED IN 5% OF GROUP P AND 0% OF GROUP D. ASPIRATION PNEUMONIA WAS OBSERVED IN 0% OF GROUP P AND 3% OF GROUP D. ALL CASES COULD BE TREATED WITH INTERNAL MEDICINE TREATMENT(TREATED MEDICALLY). THIS LITERATURE ARTICLE REPRESENTS ASPIRATION PNEUMONIA OBSERVED IN GROUP D, SINGLE USE ELECTROSURGICAL KNIFE KD-650. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669767 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-650L 04953170265761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other