BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL SINGLE USE FIBER

    MDR report key: 15966777 · Received December 13, 2022

    Report

    Report Number
    3003790304-2022-00332
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 5, 2022
    Report Date
    May 19, 2023
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE WAS RECEIVED IN A SEALED POST-MARKET POUCH AND INSPECTED ON DECEMBER 12, 2022. THE DEVICE IS CONFIRMED TO BE A TFL-FBX200S FIBER WITH A LOT NUMBER OF KR222823. DEVICE INSPECTION AND EVALUATION NOTED, THE PROXIMAL HANDLE HAS BEEN SEPARATED FROM THE REST OF THE FIBER BODY NEAR THE CONNECTOR STRAIN RELIEF. THE PROXIMAL CAP IS ON AND THERE IS LIGHT SIGNS OF MELTING AT THE STRAIN RELIEF. THE OTHER END OF THE FIBER BREAK DOES NOT SHOW SIGNS OF MELTING/ BURNING, NOTED THAT IT IS LIKELY A CLEAN BREAK. THE REST OF THE FIBER BODY DOES NOT HAVE ANY VISUAL DEFECTS AND THE DISTAL TIP APPEARS TO HAVE BEEN LIGHTLY USED WITH BURN-BACK OF THE GLASS TIP BUT NOT OF THE FIBER COATING. THIS DEVICE WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER ANALYSIS/INVESTIGATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. 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 CUSTOMER RESPONSE TO FOLLOW UP. COMMUNICATION WITH THE CUSTOMER, THE FOLLOWING INFORMATION CONVEYED : THE ISSUE OCCURRED IN THE MIDDLE OF A CYSTOURETHROSCOPY, LASER STONE MANIPULATION AND STENT PLACEMENT PROCEDURE. THERE WAS A DELAY OF APPROXIMATELY FIVE MINUTES. THE DELAY WAS TO MAKE SURE THERE WAS NO DAMAGE TO PATIENT, SURROUNDING EQUIPMENT, OR LASER. THE PROCEDURE WAS COMPLETED WITH THE SAME SIZE FIBER (MODEL: TFL-FBX200S. LOT # KR222823). ADDITIONALLY IT WAS STATED" DON'T KNOW FOR SURE THAT THE LASER FIBER WAS BUMPED, INDICATED "WAS NOT PRESENT IN THE CASE" WHEN THE ISSUE OCCURRED. NO PATIENT IMPACT AS THE RESULT OF THE EVENT. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. 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, THE ROOT CAUSE FOR THIS COMPLAINT FAILURE WAS DUE TO THE CUSTOMER "BUMPING INTO" THE LASER FIBER. THE FOLLOWING IS INCLUDED IN THE INSTRUCTIONS FOR USE: ¿DO NOT PINCH OR OTHERWISE EXCESSIVELY BEND THE FIBER WHEN LASING. FIBER FAILURE MAY OCCUR." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER BUMPED INTO THE LASER FIBER AND IT BROKE WHERE IT WAS ATTACHED TO THE LASER SYSTEM AND CAUGHT FIRE. THE CUSTOMER PUT THE FLAME OUT WITHOUT INJURY. THE INTENDED PROCEDURE WAS THERAPEUTIC. THE REPORTER DID NOT SPECIFY WHERE IN THE PROCEDURE THE EVENT OCCURRED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED AS THE RESULT OF THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER FIBER 200 MICRON SINGLE USE TFL-FBX200S, LOT KR222823). REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER SYSTEM TFL-PLS, SN (B)(4) WHERE THE FIBER WAS ATTACHED). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER FIBER 200 MICRON SINGLE USE TFL-FBX200S, LOT KR222823).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419836 200 MICRON TFL SINGLE USE FIBER TFL SINGLE USE FIBER GEX GYRUS ACMI, INC TFL-FBX200S KR222823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TFL-PLS (LASER SYSTEM).SN (B)(6).