BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLITIC

    MDR report key: 1081412 · Received July 23, 2008

    Report

    Report Number
    MW5007785
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BIOMEDICAL TECHNOLOGY
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF BIOLITIC LASER FIBER BECAME DISCONNECTED FROM REMAINDER OF FIBER DURING PROCEDURE, AFTER INSERTION INTO PT. BIOLITIC SIDEFIBER ASSEMBLY 980 NM. LASER TIP BECAME DISCONNECTED AFTER INSERTION OF PRODUCT INTO PT DURING PROCEDURE. NO HARM TO PT. DIAGNOSIS OR REASON FOR USE: TRANSURETHRAL PROSTATE RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLITIC SIDEFIBER ASSEMBLY, 980 NM GEX BIOMEDICAL TECHNOLOGY A08-0315-A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR