BEUDAMED
    FDA Adverse Event Summary report: N

    SIDEFIRE

    MDR report key: 27342 · Received April 28, 1995

    Report

    Report Number
    MW4000904
    Date Received
    April 28, 1995
    Date of Event
    April 12, 1995
    Report Date
    April 25, 1995
    Manufacturer
    SHARPLAN LASERS, INC.
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A VLAP PROCEDURE, A SMALL FRAGMENT OF GOLD TIP CAME LOOSE FROM INSIDE THE FIBER. THE CHIP AND THE FIBER WERE REMOVED AND A NEW FIBER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDEFIRE DISPOSABLE LASER FIBER GEX SHARPLAN LASERS, INC. 41115

    Patients

    Seq Age Sex Outcome Treatment
    1 *