BEUDAMED
    FDA Adverse Event Summary report: N

    HOLMIUM BARE LASER FIBER

    MDR report key: 3575272 · Received January 14, 2014

    Report

    Report Number
    3004135191-2014-00004
    Date Received
    January 14, 2014
    Date of Event
    July 17, 2013
    Report Date
    January 14, 2014
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE RENTAL COMPANY NAMED IN THE SUBJECT MEDWATCH. THE RENTAL COMPANY REPRESENTATIVE STATED THAT AFTER A NATION-WIDE SEARCH OF THEIR RENTAL DATABASE THEY WERE UNABLE TO CONFIRM AN EVENT HAD OCCURRED WITH A LUMENIS LASER ON THE EVENT DATE REPORTED IN THE MEDWATCH. THEREFORE, NO INFORMATION REGARDING THE IDENTIFICATION OF THE LUMENIS LASER WAS AVAILABLE. ADDITIONALLY, LUMENIS WAS MADE AWARE THAT THE SUBJECT LASER FIBER DELIVERY DEVICE USED IN THE PROCEDURE WAS NOT A LUMENIS PRODUCT. THE LASER FIBER DELIVERY DEVICE, LP-753, IS A PRODUCT OF LASER PERIPHERALS, LLC. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED ON MEDWATCH MW5031232 THAT A, "HOLMIUM LASER WAS BEING USED TO BREAK THE BLADDER STONE BUT THE FIBER BROKE AND THE LASER BEAM BURNED THE INSIDE OF THE SCOPE. EQUIPMENT RENTED FROM UHS SURGICAL SERVICES." THE NAME OF THE USER FACILITY WAS NOT REPORTED. LUMENIS WAS MADE AWARE OF THE EVENT REPORT DURING A PERIODIC SEARCH REVIEW OF THE FDA MAUDE WEBSITE FOR REPORTS ASSOCIATING LUMENIS AS THE MANUFACTURER. NO REPORT OF PATIENT HARM WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35288 HOLMIUM BARE LASER FIBER SURGICAL FIBER DELIVERY DEVICE GEX LASER PERIPHERALS, LLC LP-753 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1