BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    150 MICRON TFL SINGLE USE FIBER

    MDR report key: 12411032 · Received September 1, 2021

    Report

    Report Number
    3003790304-2021-00136
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 6, 2021
    Report Date
    May 26, 2022
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    UDI-DI
    00821925044043
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE UPDATES ON THE FOLLOWING SECTIONS : D4, D9, E2, E3, G3, G6, H2, H6 AND H10.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE MEDWATCH RECEIVED. THE FOLLOWING SECTIONS WERE UPDATED: B5, G2,G3, G6, H2 AND H10. USER FACILITY MW 5103158 WAS RECEIVED AND PROVIDED THE FOLLOWING ADDITIONAL DETAILS: THE LOCATION OF THE FIRE WAS NOT WITHIN THE PATIENT AREA. THE FIRE WAS EXTINGUISHED QUICKLY AS SOON AS IT STARTED BY THE CIRCULATING NURSE/LASER OPERATOR. THERE WAS NO SURGICAL DELAY IN THE PROCEDURE. THIS MW5103158 RECEIVED IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. DEVICE WAS RETURNED IN TYVEK PACKAGING ALONG WITH OTHER FIBERS AND A FOOTSWITCH. LOT NUMBER CONFIRMED TO BE KR108071. THE FAILURE MODE OF THE FIBER BEING BURNED WAS CONFIRMED BY THE BURN MARKS NEAR THE PROXIMAL END OF THE FIBER. THE REST OF THE FIBER WAS LEFT IN THE TYVEK PACKAGING WITH NO OTHER PHYSICAL ISSUES. 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, THE ROOT CAUSE ANALYSIS PERFORMED DETERMINED THAT THE FIBER FAILURE WAS DUE TO MISHANDLING. THE FIBER BROKE RIGHT BEHIND THE STRAIN RELIEF AND BURNED THE END OF IT. THIS ALLOWED LASER ENERGY TO ESCAPE FROM THE FIBER AT THE BREAK CAUSING THE STRAIN RELIEF AND/OR JACKET TO HEAT UP AND SMOKE / BURN. IF THE FIBER IS BUMPED INTO OR OTHERWISE OVER-FLEXED, IT COULD CAUSE THE FIBER TO BRAKE, ENABLE THE ESCAPE OF ENERGY AND CAUSE THE POTENTIAL FOR SMOKE / FIRE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    UPDATES ON EVENT DESCRIPTION REPORTED BY THE CUSTOMER ON MW5103158 AS BELOW. DURING SURGICAL PROCEDURE (UTEREROSCOPY WITH LASER LITHOTRIPSY STENT INSERTION) A LASER FIBER CAUGHT ON FIRE ON THE MACHINE ATTACHMENT AT THE END. THE FIRE WAS NOT WITHIN THE PATIENT AREA AND DID NOT AFFECT THE PATIENT. THE FIRE WAS EXTINGUISHED QUICKLY AS SOON AS IT STARTED BY THE CIRCULATING NURSE/LASER OPERATOR. CHARGE NURSE WAS NOTIFIED WHO NOTIFIED THE BIOMEDICAL EQUIPMENT AND OPERATING ROOM MANAGER. THE LASER FIBER WAS REMOVED AND SENT TO BIOMEDICAL EQUIPMENT FOR INSPECTION. A NEW LASER FIBER WAS THEN UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AND NO SIGNIFICANT DELAY IN CARE.

    Additional Manufacturer Narrative · 1

    DURING A CALL WITH TAC (TECHNICAL ASSISTANCE CENTER) ENGINEER SUPPORT, CUSTOMER OLYMPUS REPRESENTATIVE CONVEYED THAT THE USER FACILITY BIOMED THOUGHT HE DETECTED A KINK. THEY PLUGGED ANOTHER FIBER IN AND FINISHED THE CASE WITH NO ISSUE. TO DATE, THERE IS NO OTHER ISSUE REPORTED. TO DATE, THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED, THE FIBER SPARKED AND CAUGHT FIRE, HAPPENED WHERE THE FIBER COMES OUT OF THE SOCKET. THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SECOND TFL-FBX150S FIBER. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305231 150 MICRON TFL SINGLE USE FIBER 150 MICRON TFL SINGLE USE FIBER GEX GYRUS ACMI, INC TFL-FBX150S KR108071 00821925044043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown