BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVOYCE KTP LASER FIBER 600MM

    MDR report key: 15209697 · Received August 11, 2022

    Report

    Report Number
    15209697
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    June 27, 2022
    Report Date
    August 4, 2022
    Manufacturer
    INNOVOYCE LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LASER FIBER IS MELTED TO THE HUB OF THE SHEATH AND FIBER UNUSABLE. LOT M18522, KLF-001-600 KTP LASER FIBER 600, INNOVOYCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945019 INNOVOYCE KTP LASER FIBER 600MM POWERED LASER SURGICAL INSTRUMENT GEX INNOVOYCE LLC M18522

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown