BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLITEC

    MDR report key: 2626119 · Received June 14, 2012

    Report

    Report Number
    2626119
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 14, 2012
    Manufacturer
    BIOLITEC MEDICAL DEVICES, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A BIOLITEC 230 UM X 3.0 M LASER FIBER WAS OPENED TO BE USED #101130 FOR A UROLOGY CASE. UPON ATTACHING THE FIBER TO THE LASER MACHINE, IT WAS NOTED THAT THE AIMING BEAM WAS ON BUT THERE WAS NO LIGHT COMING OUT FROM THE FIBER. THE LASER PEDAL, WHEN PRESSED BY THE SURGEON, DID NOT SEEM TO ACTIVATE THE LASER FIBER. ANOTHER LASER FIBER WITH THE SAME REF/LOT/EXP. DATE WAS OPENED AND IT WAS NOTED TO DO THE SAME THING. A THIRD FIBER WAS OPENED WITH A DIFFERENT LOT# AND THIS FIBER WORKED. ALL OF THE FIBERS WITH THE NON-WORKING LOT #S WERE REMOVED FROM THE CABINET AND GIVEN TO MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLITEC LASER FIBER, UROLOGY GEX BIOLITEC MEDICAL DEVICES, INC. 101130 A12-0078-A
    2 BIOLITEC LASER FIBER, UROLOGY GEX BIOLITEC MEDICAL DEVICES, INC. 101130 A12-0078-A

    Patients

    Seq Age Sex Outcome Treatment
    1 *