BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 10299689 · Received July 20, 2020

    Report

    Report Number
    8010047-2020-04634
    Event Type
    Injury
    Date Received
    July 20, 2020
    Report Date
    July 21, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170208416
    PMA / PMN Number
    K092309
    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 LOT 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 WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). 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, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 14 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761280 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-630L 04953170208416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other