BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERALAS

    MDR report key: 1070707 · Received July 3, 2008

    Report

    Report Number
    1222625-2008-00003
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BIOLITEC, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY DID NOT RECEIVE A COMPLAINT FROM THE END USER AND WAS NOT AWARE OF THE EVENT. THE FIBER TIP BROKE OFF AND WAS RETRIEVED.

    Description of Event or Problem · 1

    PATIENT UNDERGOING CYSTOSCOPY WITH LASER. DURING THE PROCEDURE, THE LASER FIBER TIP BROKE OFF. IT WAS RETRIEVED. THE COMPANY DID NOT RECEIVE A COMPLAINT FROM THE END USER AND WAS NOT AWARE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERALAS FIBER OPTIC LASER DELIVERY SYSTEM GEX BIOLITEC, INC. E08-0261B

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR