BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER FIBER CONNECTION CABLE

    MDR report key: 21761139 · Received April 3, 2025

    Report

    Report Number
    21761139
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 2, 2025
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LASER MELTED AT THE CONNECTION POINT AWAY FROM THE PATIENT, LASER REPLACED, AND THE REPS WERE NOTIFIED, AND LASER FIBER SENT FOR EVALUATION WITH THE MONTERIS REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573981 LASER FIBER CONNECTION CABLE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown