BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2452215 · Received February 6, 2012

    Report

    Report Number
    2937094-2012-00149
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 20, 2011
    Report Date
    March 14, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    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

    THE DEVICE WAS RETURNED TO THE MFR AND ANALYZED. THE INITIAL REPORT INDICATED DECREASED FIBER VAPORIZATION EFFICIENCY, NOT A REPORTABLE ISSUE. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER WAS ATTACHED AND INTACT, HOWEVER CHARRED AND DRILLED THROUGH. BASED ON THE ANALYSIS FINDINGS, THE FIBER/CAP CONDITION WOULD RESULT IN FORWARD FIRING AND IS A FAILURE MODE THAT HAS BEEN IDENTIFIED AS A POTENTIAL RISK AND SAFETY ISSUE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DECREASE IN FIBER VAPORIZATION EFFICIENCY AT 33,509 JOULES DURING PROSTATE TREATMENT. THERE WAS NO PT INJURY. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMS, INNOVATION CENTER-SILICON VALLEY NA 023H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYS| AND ACCESSORIES