BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL BALL TIP SINGLE USE FIBER

    MDR report key: 16997007 · Received May 24, 2023

    Report

    Report Number
    3011050570-2023-00036
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 25, 2023
    Report Date
    August 21, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE FIBER CAUGHT ON FIRE DUE TO THE FIBER BEING MIS-HANDLED BY THE USER. THE FINAL ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS- FULL NAME OF THE ESTABLISHMENT IS (B)(6) OF THE THIRD ORDER.THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS RECEIVED AT THE FACILITY IN A SEALED, POST-MARKET POUCH AND INSPECTED ON (B)(6) 2023. THE DEVICE IS CONFIRMED TO BE A TFL-FBX 200BS LASER FIBER WITH A LOT NUMBER OF KR262852. ONLY THE PROXIMAL CONNECTOR WAS RETURNED WITH THE PROXIMAL CAP ON. THE FIBER END HAS A SMALL SECTION OF FIBER STILL CONNECTED BEYOND THE STRAIN RELIEF. THE SMALL SECTION OF FIBER APPEARS TO HAVE BURNT AND THERE IS DISCOLORATION ON THE STRAIN RELIEF. THE FIBER COATING ON THIS SECTION HAS NEARLY MELTED OFF. THE FACILITY DOES NOT HAVE THE MEANS TO TEST THE CONNECTION OF THE CONNECTOR. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE TERRITORY MANAGER REPORTED TO OLYMPUS ON BEHALF OF CUSTOMER THAT THE 200 MICRON TFL BALL TIP SINGLE USE FIBER CAUGHT FIRE AT THE BEGINNING OF THERAPEUTIC CYSTOSCOPY AND URETEROSCOPIC STONE EXTRACTION (LEFT STENT) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF DEVICE, WITHOUT ANY DELAY. THERE WERE NO REPORTS OF PATIENT HARM AND NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) ¿ LASER SYSTEM, MODEL- TFL-PLS, SN-(B)(4). REPORT WITH PATIENT IDENTIFIER (B)(6) ¿ LASER FIBER, MODEL- TFL-FBX200BS, SN- (B)(4). THIS REPORT IS BEING SUBMITTED FOR PATIENT IDENTIFIER C23210460 ¿ LASER FIBER, MODEL- TFL-FBX200BS, SN-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371754 200 MICRON TFL BALL TIP SINGLE USE FIBER POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-FBX200BS KR262852

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SOLTIVE LASER SYSTEM, TFL-PLS, MDUF220391.