BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 10263866 · Received July 13, 2020

    Report

    Report Number
    8010047-2020-04270
    Event Type
    Injury
    Date Received
    July 13, 2020
    Report Date
    July 13, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K171158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON JUN 15, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "A CASE OF GASTRIC PSEUDOANEURYSM FOLLOWING ENDOSCOPIC SUBMUCOSAL DISSECTION OF EARLY GASTRIC CANCER". IN THE LITERATURE, IT WAS REPORTED THAT BLEEDING AND PSEUDOANEURYSM WERE OBSERVED IN A PATIENT WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). DURING ESD, NO MUSCULAR LAYER OF DAMAGES OR PERFORATIONS WERE EVIDENT, AND THERE WAS NO BLEEDING THAT WAS DIFFICULT TO STOP. THE ESD PROCEDURE WAS PERFORMED USING THE ELECTROSURGICAL KNIFE (DUALKNIFE, IT-KNIFE). IN THE CASE OF BLEEDING, HEMOSTASIS WAS PERFORMED USING HIGH-FREQUENCY HEMOSTATIC FORCEPS (COAGRASPER G) AND ARGON PLASMA COAGULATION (APC). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, IN THE LITERATURE, IT WAS REPORTED THAT HIGH-FREQUENCY COAGULATION AT THE TIME OF HEMOSTASIS DURING OR AFTER ESD WAS CONSIDERED TO HAVE THE FOLLOWING INFLUENCE. A PENETRATING VESSEL FROM THE LEFT GASTRIC ARTERY IN THE MUSCULAR LAYER AT THE MUCOSAL DEFECT MAY HAVE COLLAPSED, RESULTING IN THE FORMATION OF THE PSEUDOANEURYSM, WHICH RUPTURED DUE TO THE INFLUENCE OF GASTRIC ACID. THEREFORE, OMSC WILL SUBMIT 2 MEDICAL DEVICE REPORTS (MDR) FOR EACH DEVICE. THIS REPORT IS 1 OF 2 REPORTS FOR THE ELECTROSURGICAL KNIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730094 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other