BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3151441 · Received May 30, 2013

    Report

    Report Number
    2937094-2013-00636
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    February 25, 2013
    Report Date
    April 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER CAP IS FRACTURED DISTAL TO GLUE ZONE. THE FIBER CAP EXHIBITS SEVERE CHAR, DEVITRIFICATION, AND DETRITUS. THE FIBER IS BROKEN DISTAL TO GLUE ZONE. THE BROKEN FIBER TIP SURFACE AREA EXHIBITS CHAR. THE HEAT SHRINK TUBE IS PARTIALLY MELTED AND CONTAMINATED WITH DETRITUS. BASED ON THE ANALYSIS FINDINGS THE FIBER/ CAP CONDITIONS WOULD RESULT IN FORWARD FIRING. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE LOCALIZED HEAT ACCUMULATION/ USER HANDLING CAN OCCUR WHEN TISSUE ADHERES TO THE FIBER CAP SURFACES. REFERENCE MFR# 2937094-2013-00635. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE LOCALIZED HEAT ACCUMULATION/ USER HANDLING CAN OCCUR WHEN TISSUE ADHERES TO THE FIBER CAP SURFACES. REFERENCE MFR # 2937094-2013-00635.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER DAMAGED AT TIP AT 80 JOULES. THE FIBER WAS REPLACED AND THE CASE WAS CONTINUED WITH A SECOND FIBER. THE SECOND FIBER ALSO DAMAGED AT THE TIP AT 137,609 JOULES. THE CASE WAS CONTINUED WITH A THIRD FIBER. THIS REPORT IS FOR THE SECOND FIBER. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237646 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 225H

    Patients

    Seq Age Sex Outcome Treatment
    1