BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN NEEDLE KNIFE V

    MDR report key: 14856726 · Received June 29, 2022

    Report

    Report Number
    8010047-2022-11043
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K955247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE EVALUATION, THE FOLLOWING NOTED : PRODUCT NAME: KD-V451M LOT NO .: 1YK. THE INCISION KNIFE WAS NOT BROKEN. THE SLIDER WAS OPERATED HOWEVER, IT WAS NOTED THAT IT COULD NOT STORE THE INCISION KNIFE. THE OPERATION WAS CHECKED AND FOUND WIRE WAS BROKEN NEAR THE JOINT WITH THE OPERATION PIPE. THE FRACTURED PART WAS INSPECTED AND NOTED THAT THE SHAPE OF THE DUCTILE FRACTURE COULD BE SEEN. THE OUTER DIAMETER OF THE OPERATION WIRE WAS MEASURED AND NO PROBLEM WAS OBSERVED IN ADDITION, NO ABNORMALITY WAS FOUND IN THE ACTUAL PRODUCT. EVALUATION FINDINGS FOUND THE KNIFE WIRE WAS NOT BROKEN HOWEVER, THE OPERATION WIRE OF THE OPERATION PART WAS FOUND BROKEN. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED, DURING SURGERY, THE KNIFE WIRE BREAKS AND WHEN ENERGIZED. THE OUTPUT SETTING IS UNKNOWN. THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957002 SINGLE USE 3-LUMEN NEEDLE KNIFE V SINGLE USE 3-LUMEN NEEDLE KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V451M 1YK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown