BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REUSABLE 10XL OPTICAL FIBER

    MDR report key: 23989441 · Received January 7, 2026

    Report

    Report Number
    3004378299-2025-00003
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 5, 2025
    Report Date
    January 7, 2026
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K180158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE EVENT MEETS THE CRITERIA FOR PATIENT INVOLVEMENT AND REQUIRE MEDICAL MONITORING, THE CLINICAL OUTCOME IS ATTRIBUTABLE TO MECHANICAL COMPROMISE OF THE OPTICAL FIBER DUE TO IMPROPER HANDLING. BASED ON THE EVENT DESCRIPTION AND TECHNICAL EXPERIENCE WITH SIMILAR DYNAMICS, THE OCCURENCE IS CONSISTENT WITH A VIOLATION OF THE FIBER'S MINIMUM BENDING RADIUS OR AN ACCIDENTAL BREACH OF THE PROTECTIVE CLADDING. SUCH MECHANICAL STRESS LIKELY CREATED A LOCALIZED FRACTURE POINT; THE SUBSEQUENT LEAKAGE OF OPTICAL ENERGY AT THIS SITE RESULTED IN A THERMAL HOT SPOT, LEADING TO THE OVERHEATING AND IGNITION (FLAME) OF THE OUTER JACKET AT THE POINT OF THE CRACK. CRUCIALLY, THIS CONCLUSION IS SUPPORTED BY THE FACT THAT THE FAILURE WAS TRIGGERED BY AN EXTERNAL EVENT DURING USE RATHER THAN A PRE-EXISTING STRUCTURAL OF MATERIAL FLAW. THEREFORE, THE EVENT IS CONSIDERED A DEVIATION FROM THE HANDLING PRECAUTIONS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). CONSEQUENTLY, THE DEVICE'S SAFETY PROFILE REMAINS UNCHANGED, NO SYSTEMIC DEVICE FAILURE WAS IDENTIFIED, AND NO FURTHER CORRECTIVE ACTIONS ARE PLANNED.

    Description of Event or Problem · 0

    AT THE END OF THE PROCEDURE, THE SURGICAL FIELD CAUGHT FIRE ON THE LASER FIBRE SIDE (CHECKED BEFORE THE PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49196 REUSABLE 10XL OPTICAL FIBER SURGICAL OPTICAL FIBER GEX QUANTA SYSTEM S.P.A. MF550RST

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other