BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL SINGLE USE FIBER

    MDR report key: 15327023 · Received August 31, 2022

    Report

    Report Number
    3003790304-2022-00190
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Report Date
    March 14, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925043930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS EVENT INCLUDES 2 REPORTS: (B)(6): TFL-SLS, SERIAL (B)(4). (B)(6): TFL-FBX200S, LOT KR212626. THIS REPORT IS FOR (B)(6): TFL-FBX200S, LOT KR212626. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM), HOWEVER, THE OEM ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE CUSTOMERS REPORT OF A FLAME AT THE PLASTIC CONNECTOR WHERE IT PLUGS INTO THE GENERATOR WAS CONFIRMED; A PHOTO OF THE FIBER WAS PROVIDED, SHOWING DAMAGE THAT WOULD BE CONSISTENT WITH THE REPORT. THE FIBER WAS NOT RETURNED TO OLYMPUS FOR ANY FURTHER EVALUATION AND THE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, AT THE BEGINNING OF A THERAPEUTIC ENDOLUMINAL URETERO-LITHECTOMY, THE PLASTIC CONNECTOR AT THE FIBER STARTED BURNING AND PRODUCED A FLAME WHICH 'STOOD STRAIGHT OUT ABOUT FIVE (5) CM FROM THE FIBER'S PLASTIC SLEEVE. THE FLAME WAS EXTINGUISHED WITH PAPER TOWELS (CLOSED AROUND THE FLAME). THE PROCEDURE HAD AN UNSPECIFIED DELAY WHILE THE STAFF REALIZED WHAT WAS GOING ON. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE GENERATOR DID NOT SHUT DOWN DURING THE FIRE AND THE STAFF DID NOT RESTART IT EITHER. THERE WAS NO PATIENT OR USER HARM. THIS EVENT INCLUDES 2 REPORTS: (B)(4): TFL-SLS, SERIAL (B)(4). (B)(4): TFL-FBX200S, LOT KR212626. THIS REPORT IS 2 OF 2 FOR (B)(4): TFL-FBX200S, LOT KR212626.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069466 200 MICRON TFL SINGLE USE FIBER GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM GEX GYRUS ACMI, INC. TFL-FBX200S KR212626 00821925043930

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TFL-SLS, (B)(4).