BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1941282 · Received December 16, 2010

    Report

    Report Number
    2937094-2010-01300
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    February 22, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS UNABLE TO BE RETURNED TO AMS FOR EVAL BY A QUALITY ENGINEER BECAUSE THE FIBER WAS DISPOSED OF BY THE HOSPITAL WHO PERFORMED THE PROCEDURE WITH THIS FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER FAILED BECAUSE OF THE LIKELY IMPLOSION OF THE CRYSTAL AT 46,409 JOULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 930U

    Patients

    Seq Age Sex Outcome Treatment
    1