BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 11257066 · Received February 1, 2021

    Report

    Report Number
    8010047-2021-02064
    Event Type
    Injury
    Date Received
    February 1, 2021
    Report Date
    February 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170265761
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 JANUARY 26, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "CLINICAL OUTCOMES OF AND MANAGEMENT STRATEGY FOR PERFORATIONS ASSOCIATED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION OF AN UPPER GASTROINTESTINAL EPITHELIAL NEOPLASM". THE PURPOSE WAS TO INVESTIGATE THE CLINICAL OUTCOMES OF AND MANAGEMENT STRATEGIES FOR ESD-RELATED PERFORATIONS. DETERMINE THE TECHNICAL FEASIBILITY AND ONCOLOGIC SAFETY OF DIAGNOSTIC ENDOSCOPIC RESECTION (ER). IN THE LITERATURE, IT WAS REPORTED THAT 2 INTRAOPERATIVE PERFORATIONS REQUIRED SURGERY WERE OBSERVED IN 3821 PATIENTS WHICH WERE PERFORMED THE ER BETWEEN FEBRUARY 2010 AND APRIL 2014. THE ER PROCEDURE WAS PERFORMED USING THE OLYMPUS¿S KNIFE (KD-650L, KD-10Q-1-A, KD-610L, KD-650L). HOWEVER, WE COULD NOT IDENTIFY WHAT KIND OF MODEL NUMBERS OF KNIFE THE SURGEON USED WHEN THE PERFORATION OCCURRED. IT WAS ALSO REPORTED THAT 72 INTRAOPERATIVE PERFORATIONS REQUIRED SURGERY, 16 POSTOPERATIVE PERFORATIONS, 3821 MILD-TO-MODERATE ABDOMINAL PAINS, 72 AIR ACCUMULATIONS, 30 ELEVATED CRP LEVEL, AND 40 FEVER AND ELEVATED WBC OCCURRED. 72 INTRAOPERATIVE PERFORATIONS WAS SUCCESSFULLY ENDOSCOPIC-CLIPPED. ALL 16 PATIENTS WITH POSTOPERATIVE PERFORATIONS RECOVERED AFTER CONSERVATIVE CARE. IT WAS NOT REPORTED ANY MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENT COULD NOT BE DETERMINED. HOWEVER, WE ASSUMED THAT THE PERFORATIONS MIGHT ASSOCIATE WITH ER AND DETERMINED THAT 2 INTRAOPERATIVE PERFORATIONS REQUIRED SURGERY WERE SERIOUS INJURY. THEREFORE, OMSC WILL SUBMIT 1 MEDICAL DEVICE REPORT (MDR) FOR THE 2 INTRAOPERATIVE PERFORATIONS REQUIRED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157595 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-650L 04953170265761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention