BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 10172873 · Received June 19, 2020

    Report

    Report Number
    8010047-2020-03482
    Event Type
    Injury
    Date Received
    June 19, 2020
    Report Date
    June 19, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    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 IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON MAY 21, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "MANAGEMENT OF PERFORATION RELATED TO ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL DUODENAL EPITHELIAL TUMORS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 36 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION, INCLUDING 4 PATIENTS WITH DELAYED PERFORATION AND 32 PATIENTS WITH INTRAOPERATIVE PERFORATION. IN THE 19 PATIENTS, THE PERFORATIONS COULD NOT BE COMPLETELY CLOSED AFTER ESD FOR THE ENTIRE MUCOSAL DEFECT. THE CLINICAL OUTCOMES OF PATIENTS WITH COMPLETE CLOSURE WERE MORE SUCCESSFUL THAN PATIENTS WITHOUT COMPLETE CLOSURE. THE ESD PROCEDURE WAS PERFORMED USING THE ELECTROSURGICAL KNIFE (DUALKNIFE, DUALKNIFE J, HOOKKNIFE). 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 19 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 15 OF 19 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE ELECTROSURGICAL KNIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639266 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other