BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURA XP

    MDR report key: 2081115 · Received April 14, 2011

    Report

    Report Number
    2937094-2011-00646
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AMS, INNOVATION CTR - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K951034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THERE WAS AN ENDOSTAT OOB DEFECT; THE FIBER WAS FRAYED IN THE MIDDLE FROM OUT OF THE BOX. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURA XP SURGICAL FIBER GEX AMS, INNOVATION CTR - SILICON VALLEY NA 034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other