BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2452190 · Received February 6, 2012

    Report

    Report Number
    2937094-2012-00151
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    December 28, 2010
    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 CAP WAS ATTACHED AND INTACT, HOWEVER WORN, SHOWING EVIDENCE OF CHAR AND DEVITRIFICATION; THE CAP WAS ALSO FOUND TO BE DRILLED THROUGH. BASED ON THE ANALYSIS FINDINGS, THE CAP CONDITION WOULD RESULT IN FORWARD FIRING AND HAS BEEN IDENTIFIED AS A POTENTIAL RISK AND SAFETY ISSUE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE ACCELERATED CAP WEAR RESULTING FROM HEAT ACCUMULATION DUE TO PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THE PRODUCT LABELING (PRODUCT INSERT (B)(4)) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY RESULT FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DIMINISHED VAPORIZATION AT 24,693 JOULES DURING PROSTATE TREATMENT. NO PT INJURY WAS REPORTED. THE PT OUTCOME WAS REPORTED AS "OKAY." 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 022H

    Patients

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