BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL BALL TIP SINGLE USE FIBER

    MDR report key: 15548597 · Received October 6, 2022

    Report

    Report Number
    3003790304-2022-00262
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 7, 2022
    Report Date
    March 27, 2023
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AT OLYMPUS SERVICE BUSINESS CENTER ON (B)(6) 2022 AND IS BEING SHIPPED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR INVESTIGATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. 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 DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE EVALUATION WAS COMPLETED. DURING DEVICE EVALUATION, THE PHENOMENON WAS NOT REPRODUCED. AS THERE ARE NO ABNORMALITIES AS WELL AS IN APPEARANCE, WE COULD NOT DETERMINE THE CAUSE OF THE PHENOMENON BASED ON THE INVESTIGATION RESULT. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE REVIEWED FOR THIS DEVICE HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. IT HAS BEEN ALMOST 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE NO DEVICE MALFUNCTION WAS CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A THERAPEUTIC URETEROSCOPY WITH KIDNEY STONE LITHOTRIPSY PROCEDURE USING THE SOLTIVE LASER (SERIAL NUMBER (B)(4)) WITH A 200 MICRON BALL TIP FIBER, A FIRE OCCURRED AROUND THE POINT WHERE THE LASER FIBER PLUG CONNECT TO THE LASER. THE STONE HAD BEEN TREATED AT THIS STAGE. THE STAFF HAD TO EXTINGUISH THE FIRE. ACCORDING TO THE REPORTER, IT WAS THE FIRST LASER CASE OF THE DAY. THE CUSTOMER USED A BOSTON LITHOVUE SINGLE-USE URETEROSCOPE. USED A 200 MICRON BALL TIP FIBER. USED PROF. MANECKSHA¿S PRESET FOR THE KIDNEY STONE (0.2J/60HZ/SHORT PW ON LEFT PEDAL AND 0.6J/30HZ/SHORT PW ON RIGHT PEDAL). THE NURSE WAS ASKED TO INCREASE THE AIMING BEAM TO 3, THIS WAS UNUSUAL. SHORTLY AFTER, A FLAME WAS NOTICED ON THE FIBER PLUG. THE NURSE PUSHED THE EMERGENCY STOP BUTTON THEN TOOK SOME WET GAUZE TO EXTINGUISH THE FLAME. THE PLUG WAS DETACHED FROM THE FIBER AT THIS POINT. THE PLUG WAS THEN REMOVED FROM THE SOCKET. ANOTHER FIBER WAS INSERTED AND THE CASE CONTINUED TO COMPLETION. NO INJURIES OCCURRED TO STAFF OR THE PATIENT. THE PROCEDURE WAS SLIGHTLY PROLONGED WHILE ALL OF THE ABOVE OCCURRED. NO ADVERSE EFFECT TO THE OUTCOME WAS NOTED. THE FIBER USED AND ONE REMAINING FIBER FROM THE BOX WAS COLLECTED AND WILL BE SENT FOR INSPECTION. A FIELD SERVICE ENGINEER WAS REQUESTED TO INSPECT THE LASER SYSTEM (SOLTIVE LASER). IN A FOLLOW UP COMMUNICATION, THE CUSTOMER REPRESENTATIVE CONFIRMED THAT NO DELAY TO PROCEDURE , NO PATIENT HARMED, NO HARM TO CLINICAL STAFF. THERE WAS NO ERROR ON UNIT (LASER UNIT) , USER REPLACED THE FIBER AND COMPLETED THE PROCEDURE. THIS EVENT INCLUDES TWO (2) REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (DAMAGED LASER FIBER LOT KR200126). REPORT WITH PATIENT IDENTIFIER (B)(6) (ONE REMAINING LASER FIBER IN THE BOX LOT KR200126-RETURNING FOR INSPECTION/EVALUATION). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (ONE REMAINING LASER FIBER IN THE BOX LOT KR200126-RETURNING FOR INSPECTION/EVALUATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257665 200 MICRON TFL BALL TIP SINGLE USE FIBER TFL BALL TIP SINGLE USE FIBER GEX GYRUS ACMI, INC TFL-FBX200BS KR200126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LASER UNIT SN:(B)(6)URETEROSCOPE FOOTPEDAL