BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HIPS FIBER

    MDR report key: 2903709 · Received January 4, 2013

    Report

    Report Number
    2937094-2013-00013
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    January 19, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE DRILLED THROUGH. THE CAP WAS ALSO FOUND TO EXHIBIT DETRITUS, CHAR AND DEVITRIFICATION. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSE BEAM AND REDUCED TISSUE VAPORIZATION EFFICIENCY. THE DRILLED THROUGH FIBER CAP CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. 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, LIMITING THE PERFORMANCE OF THE FIBER.

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE DRILLED THROUGH. THE CAP WAS ALSO FOUND TO EXHIBIT DETRITUS, CHAR AND DEVITRIFICATION. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSE BEAM AND REDUCED TISSUE VAPORIZATION EFFICIENCY. THE DRILLED THROUGH FIBER CAP CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. 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, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SURGICAL FIBER WAS DAMAGED DURING A PROSTATE PROCEDURE. THE PHYSICIAN DID NOT USE ANOTHER FIBER BUT INSTEAD, CHOSE TO REVERT TO TURP TO COMPLETE THE CASE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4178 AMS GREENLIGHT HIPS FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 043H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT HPS LASER SYSTEM| ACCESSORIES