BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON TFL SINGLE USE FIBER

    MDR report key: 16281251 · Received February 1, 2023

    Report

    Report Number
    3003790304-2023-00038
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Report Date
    May 24, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925043930
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTIONS TO E2 AND G2. PLEASE SEE UPDATES TO D4, E2, G2, H4, H6 AND H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE FIBER SPLITTING COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. IN A FOLLOW COMMUNICATION WITH THE CUSTOMER, IT WAS CONVEYED THAT THE FOUR (4) FIBERS (SUBJECT DEVICE) WERE NOT AVAILABLE ANYMORE. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE REPORTED THE LASER FIBERS ARE BROKEN. ACCORDING TO THE REPORT, THE LASER FIBERS (MODEL TFL-FBX200S ) WERE UNPACKED, FOUND THE "FIBERS HAVE BEEN SLIGHTLY SPLIT, THE TWO LASER BEAMS ARE VISIBLE". THE FAILURE OCCURRED ON FOUR (4) OF THE SAME LOT (LOT KR233070). THE ISSUE FOUND AT PREPARATION FOR USE. NO HARM REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED. THIS EVENT INCLUDES FOUR (4) REPORTS TO ADDRESS THE REPORTED FOUR (4) BROKEN FIBERS. REPORT WITH PATIENT IDENTIFIER (B)(6) (1 OF 4). REPORT WITH PATIENT IDENTIFIER (B)(6) (2 OF 4). REPORT WITH PATIENT IDENTIFIER (B)(6) (3 OF 4). REPORT WITH PATIENT IDENTIFIER (B)(6) (4 OF 4). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (1 OF 4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384779 200 MICRON TFL SINGLE USE FIBER SINGLE USE FIBER GEX GYRUS ACMI, INC. TFL-FBX200S KR233070 00821925043930

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown