BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL SINGLE USE FIBER

    MDR report key: 16330578 · Received February 8, 2023

    Report

    Report Number
    3003790304-2023-00053
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 11, 2023
    Report Date
    May 31, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO E2, E3 (INADVERTENTLY LEFT OFF THE INITIAL REPORT). 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, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO MISHANDLING OF THIS LASER FIBER NEAR THE CONNECTOR END. THE MISHANDLING LIKELY CAUSED A SMALL BREAK WHICH IGNITED WHEN THE CONSOLE WAS FIRING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED AT SERVICE BUSINESS CENTER (SBC) OLYMPUS ON (B)(6) 2023. INITIAL EVALUATION WAS PERFORMED. VISUAL INSPECTION NOTED THE DEVICE WAS RECEIVED IN A SEALED POST-MARKET POUCH , CONFIRMED TO BE A TFL-FBX200S SOLTIVE LASER FIBER WITH A LOT NUMBER OF KR222895. INSPECTION FOUND THE CONNECTOR END IS SEPARATED FROM THE FIBER BODY AND THERE IS MELTING AND DISCOLORATION AT THE STRAIN RELIEF. THE BROKEN FIBER END DOES NOT HAVE DISCOLORATION OR SIGNS OF BURNING. THE DISTAL TIP IS INTACT AND APPEARS TO BE UNUSED. THE LENGTH OF THE FIBER BODY DOES NOT HAVE ANY PHYSICAL DEFECTS OTHER THAN THE BROKEN END. THE DEVICE IS BEING SHIPPED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER ANALYSIS. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE (OLYMPUS REP.) REPORTED THE USER WAS TRYING TO FIRE THE LASER AND NOT GETTING ANY RESULTS, AFTER A FEW SECONDS, WHEN TURNED AROUND SAW "LITTLE FLAME" AT THE FIBER CONNECTION TO THE SOLTIVE LASER. THE ISSUE OCCURRED AT PREPARATION FOR USE FOR A URETEROSTOMY (THERAPEUTIC PROCEDURE ). THE DEVICE WAS REPLACED (LASER FIBER) AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE DEVICE AT THE TIME OF THE EVENT IS BEING USED WITH A LASER SYSTEM (TFL-PLS SOLTIVE PREMIUM LASER SYSTEM, SN (B)(4)). NO HARM REPORTED, NO PATIENT INJURY, NO USER/STAFF INJURY AS THE RESULT OF THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (FL-FBX200S SOLTIVE LASER FIBER , LOT KR222895). REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-PLS SOLTIVE PREMIUM LASER SYSTEM, SN (B)(4)) THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (FL-FBX200S SOLTIVE LASER FIBER , LOT KR222895).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957669 200 MICRON TFL SINGLE USE FIBER TFL SINGLE USE FIBER GEX GYRUS ACMI, INC. TFL-FBX200S KR222895

    Patients

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