BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSATOME SLIMLINE (550)

    MDR report key: 102388 · Received July 1, 1997

    Report

    Report Number
    2914019-1997-00020
    Event Type
    Other
    Date Received
    July 1, 1997
    Date of Event
    May 29, 1997
    Report Date
    May 30, 1997
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H.3 - THE USER FACILITY HAS NOT SENT A REPORT OF THEIR FINDINGS. THE FACILITY DID SEND THE FIBER TO COHERENT 1 1/2 YRS. AFTER THE INCIDENT. THE FIBER COULD NOT BE VERIFIED AS BEING THE SAME FIBER INVOLVED IN THE INCIDENT AS THE LOT NUMBER WAS DIFFERENT THAN ORIGINALLY REPORTED BY THE FACILITY. COHERENT'S ANALYSIS OF THE FIBER THAT WAS SENT REVEALED THAT THIS TYPE OF FAILURE IS USUALLY CAUSED BY APPLICATION OF FORCE AGAINST THE FIBER WHICH RESULTS IN A DEFORMATION OF THE FIBER BEYOND THE ALLOWABLE BEND RADIUS AS SPECIFIED IN THE MANUAL. ALL FIBERS ARE 100% INSPECTED DURING MFG AND HIGH POWER LASER TESTED PRIOR TO SHIPPING.

    Description of Event or Problem · 1

    DR WAS DOING LASER TREATMENT FOR TUMOR ABLATION IN THE BRONCHUS AREA. THE LASER FIBER SPARKED AND DR EXTRACTED THE FIBER. PT EXPERIENCED BLANCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSATOME SLIMLINE (550) FIBER GEX COHERENT MEDICAL GROUP NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *