BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX LASER FIBER

    MDR report key: 2193621 · Received July 14, 2011

    Report

    Report Number
    2937094-2011-01430
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AMERICAN MEDIAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE PROCEDURE AFTER ABOUT 2 MINUTES A SHOCK WAS SPONTANEOUSLY FELT IN THE UTEROSCOPE. PER THE CUSTOMER, THE PROCEDURE WAS STOPPED IMMEDIATELY. THE CUSTOMER REPORTED THE FIBER TIP WAS BROKE, 4 CM, AND WAS IN THE PATIENT'S KIDNEY. PER THE CUSTOMER, THE FIBER WAS TESTED BEFORE BEING INTRODUCED INTO THE LASER. PER THE CUSTOMER, THE FIBER TIP WAS REMOVED FROM THE PATIENT'S KIDNEY WITH FORCEPS. THE CUSTOMER REPORTED THIS RESULTED IN A SUPERFICIAL TRAUMA OF THE PATIENT'S URETHRA DUE TO THE SIZE OF THE FIBER FRAGMENT. PER THE CUSTOMER, THE LASER PROCEDURE WAS STOPPED EVEN THOUGH THE STONES WERE NOT CUT INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLEX LASER FIBER SUREFLEX FIBER GEX AMERICAN MEDIAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA TRF08110B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R