BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-655

    MDR report key: 10429382 · Received August 20, 2020

    Report

    Report Number
    8010047-2020-05627
    Event Type
    Injury
    Date Received
    August 20, 2020
    Report Date
    August 20, 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 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 JULY 27, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "MULTICENTER PROSPECTIVE JOINT STUDY ON EFFICACY AND SAFETY OF COLORECTAL ESD IN HIROSHIMA AREA". IN THE LITERATURE, IT WAS REPORTED THAT COMPLICATIONS OF INTRAOPERATIVE PERFORATION, POSTOPERATIVE BLEEDING, AND POSTOPERATIVE PERFORATION OCCURRED USING THE SUBJECT DEVICE AND THE COMPETITOR'S DEVICE "SB KNIFE". THIS STUDY WAS CONDUCTED COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ON 2334 PATIENTS BETWEEN AUGUST 2018 AND DECEMBER 2018 IN THE HIROSHIMA AREA. THE REPORTED POSTOPERATIVE BLEEDING AND POSTOPERATIVE PERFORATION WERE NOT ABLE TO IDENTIFY WITH RELATION TO THE SUBJECT DEVICE SINCE IT WAS NOT REPORTED THAT A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE OBSERVED ADVERSE EVENTS. IN CONTRAST, OMSC ASSUME THAT THE COMPLICATION OF THE INTRAOPERATIVE PERFORATION WAS RELATED TO THE SUBJECT DEVICE SINCE THE ESD PROCEDURE WAS USED SUBJECT DEVICE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THEREFORE, OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) FOR THE INTRAOPERATIVE PERFORATION OF THE ELECTROSURGICAL KNIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896020 SINGLE USE ELECTROSURGICAL KNIFE KD-655 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other