BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAM SINGLE-USE HOLMIUM LASER FIBERS

    MDR report key: 3243071 · Received July 18, 2013

    Report

    Report Number
    1018233-2013-02910
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    GEX
    PMA / PMN Number
    K120926
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS AWAITING RECEIPT OF THE SAMPLE TO COMPLETE AN INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE TIP BROKE OFF IN THE PT. THE GENERATOR USED WAS A LUMENIS VERSAPULSE 100 DURING THE URETEROSCOPY. THE TIP WAS NOT CLEAVED AND STRIPPED, DEVICE WAS FIRED INSIDE THE SCOPE. IT APPEARED THAT THERE WAS FRACTURE ON THE TIP BEFORE THE DOCTOR FIRED THE LASER. THE TIP WAS FLUSHED OUT OF THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336364 BEAM SINGLE-USE HOLMIUM LASER FIBERS GEX C.R. BARD, INC. (COVINGTON) NA BMWHG013

    Patients

    Seq Age Sex Outcome Treatment
    1