BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTTRAIL REUSABLE

    MDR report key: 24274526 · Received February 5, 2026

    Report

    Report Number
    2124215-2026-06777
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729895084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE PRODUCT RECORD REVIEW (PRR) RESULTS DETAILED IN THE PRR TABLE DID NOT DETERMINE PROBABLE CAUSE. A RISK REVIEW WAS PERFORMED AND CONFIRMED THAT THE REPORTED EVENT OF THE DEVICE THAT IT STOPPED WORKING, A DETACHMENT OF THE DEVICE OR DEVICE COMPONENT, AND THE OVERHEATING OF THE DEVICE OR DEVICE COMPONENT, WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. A LABELING REVIEW WAS PERFORMED ON THE DEVICE INSTRUCTIONS FOR USE (IFU). THE IFU CITED THAT THE FIBER SHOULD NOT BE CLAMPED WITH FORCEPS OR OTHER SECURING INSTRUMENTS AS IT COULD RESULT IN FIBER DAMAGE OR BREAKAGE. DO NOT BEND FIBER AT SHARP ANGLES. RESIDUES OF BLOOD AND TISSUE AND/OR DAMAGE CAN LEAD TO OVERHEATING OF THE LIGHTTRAIL REUSABLE LASER FIBER TIP. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION FINDINGS DO NOT CLEARLY CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE, THUS THE CONCLUSION CODE "UNABLE TO EXCLUDE DEVICE PROBLEM" HAS BEEN ASSIGNED AS THE MOST PROBABLE CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER STOPPED WORKING ON THE THIRD USE. IT WAS NOTED THAT A PART OF THE FIBER DETACHED, HOWEVER, THERE WAS NO FRAGMENTS FELL INSIDE THE PATIENT. IT WAS ALSO NOTED THAT THE FIBER OPTIC CABLE SEEMED TO HAVE BURNED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER STOPPED WORKING ON THE THIRD USE. IT WAS NOTED THAT A PART OF THE FIBER DETACHED, HOWEVER, THERE WAS NO FRAGMENTS FELL INSIDE THE PATIENT. IT WAS ALSO NOTED THAT THE FIBER OPTIC CABLE SEEMED TO HAVE BURNED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407168 LIGHTTRAIL REUSABLE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 6463 08714729895084

    Patients

    Seq Age Sex Outcome Treatment
    1