BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 4792460 · Received May 22, 2015

    Report

    Report Number
    3005099803-2015-01409
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE FLEXIVA 200 LASER FIBER WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED THAT THE EXPOSED GLASS TIP MEASURED 3.5MM AND APPEARED UNUSED. 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, INDICATING THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR. FUNCTIONAL ANALYSIS REVEALED THAT THE ¿ATTACH LASER FIBER¿ MESSAGE CLEARED FROM THE CONSOLE AFTER ATTACHMENT INDICATING THAT THE FIBER WAS RECOGNIZED BY THE LASER UNIT. NO AIMING BEAM WAS VISIBLE; THEREFORE, THE CONDITION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. GIVEN THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. 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)(6) 2015 THAT A FLEXIVA 200 LASER FIBER WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, NO AIMING BEAM WAS COMING OUT FROM THE LASER FIBER. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336831 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403911 C000001596

    Patients

    Seq Age Sex Outcome Treatment
    1