BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 10082665 · Received May 22, 2020

    Report

    Report Number
    8010047-2020-02866
    Event Type
    Injury
    Date Received
    May 22, 2020
    Report Date
    May 22, 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. BASED ON THE REPORTED EVENT, IT IS PRESUMED THAT THE REPORTED COMPLICATION WAS NOT DUE TO THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    ON APRIL 27, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED ¿EFFICACY AND SUITABLE INDICATION OF COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION USING A BALLOON-ASSISTED ENDOSCOPE¿. IN THE LITERATURE, IT WAS REPORTED THAT INTRAOPERATIVE PERFORATION OCCURRED WITH TWO PATIENTS AND POST OPERATIVE BLEEDING OCCURRED WITH ONE PATIENT. TWO CASES OF PERFORATION WERE CONSERVATIVELY MANAGED BY MEDICAL TREATMENT AFTER ENDOSCOPIC CLOSURE USING ENDOCLIPS. THE POSTOPERATIVE BLEEDING WAS MANAGED CONSERVATIVELY USING ENDOCLIPS. THE LITERATURE INDICATED THAT THE ELECTROSURGICAL KNIFE (KD-650Q OR KD-620QR) MIGHT BE USED FOR THE PROCEDURE. 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 2 MEDICAL DEVICE REPORTS (MDR) FOR EACH EVENT. THIS REPORT IS 1 OF 2 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE ELECTROSURGICAL KNIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546351 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other