BEUDAMED
    FDA Adverse Event Summary report: N

    CERALAS

    MDR report key: 1134254 · Received August 18, 2008

    Report

    Report Number
    1222625-2008-00005
    Date Received
    August 18, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BIOLITEC
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF FIBER OPTIC BROKE DURING A TRANSURETHRAL PROSTATE RESECTION. NO HARM TO PT. CO IS REFERENCING REPORT AND JUST BECAME AWARE OF THE EVENT. NO COMPLAINT WAS SUBMITTED TO CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERALAS FIBER OPTIC LASER DELIVERY SYSTEM GEX BIOLITEC SF 980 DL A08-0315A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN