BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL SINGLE USE FIBER

    MDR report key: 15546458 · Received October 5, 2022

    Report

    Report Number
    3003790304-2022-00259
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 7, 2022
    Report Date
    May 3, 2023
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED IN A POST-MARKET, AUTO-CLAVED POUCH AND INITIAL, VISUAL INSPECTION PERFORMED ON (B)(6) 2022. THE DEVICE CONFIRMED TO BE A TFL-FBX200BS WITH LOT NUMBER KR222848. THE FIBER BODY HAS NOT BEEN RETURNED AND APPEARS TO HAVE BEEN SEVERED OR BURNT COMPLETELY OFF. THE PROXIMAL CAP IS ON. THE STRAIN RELIEF/ CONNECTOR END APPEARS TO HAVE SERIOUS MELTING AND EVIDENCE OF BURNING. IT IS DIFFICULT TO TELL IF THE FIBER BROKE WITHIN THE CONNECTOR END OR SLIGHTLY BEFORE AND THEN BURNT THE STRAIN RELIEF. THE SUBJECT DEVICE WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER ANALYSIS PER THEIR REQUEST AND TO OBTAIN A DEVICE HISTORY RECORD (DHR). INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    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, FAILURE IS MOST LIKELY RELATED TO DEVICE MISHANDLING CAUSING THE FIBER TO BREAK AND IGNITE. INFORMATION FROM THE INSTRUCTIONS FOR USE MAY HELP LOWER THE INCIDENCE OF THIS FAILURE MODE IN THE FUTURE INCLUDE THE FOLLOWING: "DO NOT BEND OR COIL THE SOLTIVE LASER FIBERS BEYOND THE RECOMMENDED MINIMUM BEND RADIUS (TABLE 2); DOING SO MAY RESULT IN LIGHT LEAKAGE OR FIBER BREAKAGE THAT COULD CAUSE PERSONAL INJURY IF THE LASER IS FIRED (REFER TO THE LASER SYSTEM MANUAL). CARE MUST BE TAKEN TO AVOID EXCEEDING THE MINIMUM BEND RADIUS OF FIBERS. ALWAYS CHECK THE LASER AIMING BEAM AT THE TIP OF THE FIBER BEFORE DELIVERING HIGH ENERGIES OR DAMAGE TO THE ENDOSCOPE MAY RESULT." "5. ACTIVATE THE LASER AIMING BEAM. 6. VISUALLY INSPECT THE ENTIRE LENGTH OF FIBER FOR FLAWS OR DEFECTS BEFORE USE. IF ANY DAMAGE IS OBSERVED SUCH AS BREAKS, KINKS OR DAMAGED COMPONENTS, DO NOT USE THE FIBER, RETAIN THE DEVICE FOR MANUFACTURER NOTIFICATION AND USE A REPLACEMENT FIBER." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED "THE FIBER SPARKED NEAR THE CONNECTION TO THE MACHINE ONCE THE FOOT PEDAL WAS ACTIVATED. THIS HAPPENED DURING A KIDNEY STONE URETEROSCOPY. THE PROCEDURE WAS COMPLETED WITH A NEW FIBER. THEY WERE USING THE PRE SET FOR SURGEON FOR KIDNEY STONE. NO ERRORS DISPLAYED ON THE LASER. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554280 200 MICRON TFL SINGLE USE FIBER SINGLE USE FIBER GEX GYRUS ACMI, INC TFL-FBX200S KR222848

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LASER SYSTEM SN (B)(4)FOOTPEDAL