BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2030475 · Received March 9, 2011

    Report

    Report Number
    2937094-2011-00342
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K010284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO AMS DID NOT INDICATE A POTENTIAL PATIENT SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO AMS AND ANALYZED. THE INFORMATION FROM THIS FAILURE ANALYSIS WAS RECEIVED ON (B)(4) 2011 AND THE RESULTS OF THE FAILURE ANALYSIS INDICATED THAT AN MDR WAS REQUIRED. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP WAS DETACHED AND WORN OUT. THE FIBER CARD REPORTED 2,967 JOULES USED. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE USED AND ACCELERATED BY TISSUE CONTACT. THE PRODUCT LABELING (PRODUCT INSERT 0127-1410) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE PRODUCT LABELING ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PATIENT AND INSTRUCTIONS FOR RETRIEVING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(4) 2010 THE FIBER WAS BEING RETURNED BECAUSE IT WAS BROKEN OUT OF THE PACKAGE. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP WAS DETACHED AND 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 938G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other