BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2442507 · Received January 20, 2012

    Report

    Report Number
    2937094-2012-00095
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    AMS INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO FROM THE DISTRIBUTOR REGARDING THIS CASE WAS THAT THE PHYSICIAN'S TECHNIQUE WAS NOT PARTICULARLY GOOD; THE FIBER TIP WAS NOT PROPERLY CLEANED AND THE PHYSICIAN WAS HOLDING THE TIP TOO CLOSE TO THE TISSUE. THE DEVICE WAS RETURNED TO THE MFR AND ANALYZED. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP WAS ATTACHED AND INTACT, HOWEVER, THE CAP WAS CHARRED AND DRILLED THROUGH. THE DRILLED-THROUGH CAP CONDITION HAS THE POTENTIAL TO RESULT IN FORWARD-FIRING INSTEAD OF SIDE-FIRING. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, ACCELERATING THE FIBER CAP WEAR AND LIMITING THE PERFORMANCE OF THE FIBER. THE PRODUCT LABELING (PRODUCT INSERT (B)(4)) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. (B)(4), FIBER, IS USED IN CONJUNCTION WITH (B)(4), OUTPUT ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DECREASE IN FIBER VAPORIZATION EFFICIENCY AT 112,749 JOULES. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO PT INJURY WAS REPORTED. REFERENCE MFR# 2937094-2012-00096 REGARDING THE SECOND FIBER USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMS INNOVATION CENTER-SILICON VALLEY 0010-2090 107H

    Patients

    Seq Age Sex Outcome Treatment
    1