BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2110033 · Received May 17, 2011

    Report

    Report Number
    2937094-2011-01057
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    October 20, 2010
    Report Date
    November 15, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT INITIALLY PROVIDE INFO FOR THE FIBER PROBLEM WHEN THE CASE WAS INITIATED. THE DEVICE WAS RETURNED TO AMS AND ANALYZED. THE INFO FROM THIS FAILURE ANALYSIS WAS RECEIVED ON (B)(6) 2011 AND THE RESULTS OF THE FAILURE ANALYSIS INDICATED THAT AN MDR WAS REQUIRED. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP WAS WORN OUT. THE FIBER CAP WAS INTACT AND STILL ATTACHED. THE FIBER CAP WAS DRILLED THROUGH. THE FIBER CAP EXHIBITED DEVITRIFICATION, CRATER AND MELTED GLASS. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE USE AND ACCELERATED BY TISSUE CONTACT. THE PRODUCT LABELING (PRODUCT INSERT (B)(4)) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE PRODUCT LABELING ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PT AND INSTRUCTIONS FOR RETRIEVING.

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT INITIALLY PROVIDE INFO FOR THE FIBER PROBLEM WHEN THE CASE WAS INITIATED. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP WAS WORN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 010H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other