BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 3852070 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02160
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K082928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF FIBER MISFIRED. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUMAX LASER FIBER WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE LASER FIBER WAS TESTED AND THE AIMING BEAM LEAKED 10CM FROM THE TIP OF THE LASER FIBER. THE LASER FIBER WAS CUT BEYOND THE LEAK AND WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329761 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404012 ML00002027

    Patients

    Seq Age Sex Outcome Treatment
    1