BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 6156186 · Received December 8, 2016

    Report

    Report Number
    3005099803-2016-03715
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION FINDINGS OF FIBER BROKEN WITHIN THE CONNECTOR. ONE FLEXIVA 200 TRACTIP LASER FIBER WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE EXPOSED GLASS FIBER TIP MEASURED APPROXIMATELY 3.5 MM AND APPEARED UNUSED. ADDITIONAL EXAMINATION UNDER MAGNIFICATION CONFIRMED THAT THE FIBER TIP WAS UNUSED. THERE WAS NO DAMAGE ALONG THE BODY OF THE FIBER. THE INVESTIGATOR WAS UNABLE TO EXAMINE THE FIBER FACE WITHIN THE SUB MINIATURE-A (SMA) CONNECTOR BECAUSE LIGHT WAS UNABLE TO TRAVEL TO THE FIBER FACE, THIS INDICATED THAT THE FIBER WAS BROKEN WITHIN CONNECTOR. AS A RESULT, NO AIMING BEAM WAS VISIBLE AND EFFECTIVE TRANSMISSION WAS NOT MEASURED. FUNCTIONAL ANALYSIS REVEALED THAT THE ¿ATTACH LASER FIBER¿ MESSAGE CLEARED THE CONSOLE AFTER ATTACHMENT INDICATING THAT THE FIBER WAS RECOGNIZED BY THE LASER UNIT. THE CONDITION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING THE PROCEDURE AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2016 THAT A FLEXIVA 200 TRACTIP LASER FIBER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM COHERENT 100 WATT WITH LASER SETTINGS OF 1.5 JOULES, 10 HTZ AND 15 WATTS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THERE WAS A CLICKING SOUND HEARD AND NO ENERGY WAS COMING OUT FROM THE LASER FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806451 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403960 C000003651

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR