BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL BALL TIP SINGLE USE FIBER

    MDR report key: 18708067 · Received February 14, 2024

    Report

    Report Number
    3003790304-2024-00018
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    September 22, 2023
    Report Date
    February 14, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE FIBER WAS BROKEN AT THE STRAIN RELIEF SECTION OF THE FIBER NEAR THE PROXIMAL HANDLE. THERE IS DISCOLORATION AND EVIDENCE OF MELTING AT THE END OF THE STRAIN RELIEF. THE BROKEN END APPEARS TO HAVE BEEN A ROUGH BREAK WITH POSSIBLE SIGNS OF BURNING/ DISCOLORATION ON THE NON-CONNECTOR BREAK SIDE. THE EVIDENCE SUGGESTS THE FIBER BREAK WAS PRESENT UPON THE INITIAL FIRING OF THE LASER. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST LIKELY CAUSE FOR THE ISSUE WAS DUE TO USER-HANDLING. THE EXACT USER-HANDLING ISSUE CANNOT BE IDENTIFIED. THE FIBER LIKELY BROKE AT THE STRAIN RELIEF POINT DUE TO A FORCE EXERTED ON THE STRAIN RELIEF POINT RESULTING IN A FIBER BREAK WHICH RESULTED IN ENERGY ESCAPING THE FIBER AND IGNITING THE COATING. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THIS REPORT IS RELATED TO MFR 00401 (1/2) OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BALL TIP SINGLE USE FIBER CRACKED AND A FLAME WAS PRESENT AT THE LASER PORT ON THE LASER SYSTEM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809496 200 MICRON TFL BALL TIP SINGLE USE FIBER POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-FBX200BS KR337688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TFL-PLS.