BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX LASER FIBER

    MDR report key: 2171402 · Received June 30, 2011

    Report

    Report Number
    2937094-2011-01359
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER BLEW. PER THE CUSTOMER, THE FIBER DID NOT ALLOW ANY ENERGY TO TRANSMIT. THE CONNECTOR TO THE MACHINE WAS VERY HOT. THE CUSTOMER REPORTED THE FIBER WAS OBSERVED WITH A SCOPE AND WAS BLACK. ALSO, THE CUSTOMER REPORTED 15 WATTS OF ENERGY WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLEX LASER FIBER SUREFLEX FIBER GEX AMS, INNOVATION CENTER-SILICON VALLEY NA R-200-1022B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other