BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASERSCOPE

    MDR report key: 2429117 · Received December 30, 2011

    Report

    Report Number
    2429117
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Date of Event
    July 20, 2011
    Report Date
    December 30, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    USING A LASERSCOPE KTP LASER FOR CASE ON A (B)(6) MONTH OLD. RN BROUGHT THE LASER INTO THE ROOM, PLUGGED IT IN, TURNED THE FUSE SWITCH ON AND THEN STARTED THE LASER. AT ABOUT THE 2 MIN REMAINING IN THE 5 MIN SELF-CHECK, THE LASER BEEPED AND AN ERROR CODE OF L051 WAS BLINKING. RN TURNED IT OFF AND BACK ON AGAIN AND THE UNIT WENT INTO THE NORMAL SCREEN TO LET US KNOW THAT IT WAS READY FOR USE. RN TURNED IT OFF AS WE NORMALLY DO. RN TOLD THE STAFF THAT THE LASER WAS READY AND THEY BROUGHT THE PATIENT IN. THE DOCTOR GAVE THE RN THE NORMAL 5 MINUTE WARNING THAT WE WERE GOING TO USE THE LASER AND ASKED HER TO TURN IT ON. THE KTP LASER DID THE SAME THING AS BEFORE. WHEN THE RN TURNED ON THE LASER, ABOUT 3 MINUTES INTO THE SELF-CHECK, IT AGAIN DISPLAYED AN ERROR CODE OF L051. SHE TURNED IT OFF AND BACK ON AGAIN AND IT WENT INTO ITS NORMAL SCREEN. RN GAVE THEM A 0.2MM LASERSCOPE ENDOSTAT FIBER (LOT#10-0952-022). WE PLUGGED IT INTO PORT II. DOCTOR SAID HE WAS READY AND WE CHANGED THE LASER FROM STANDBY TO READY MODE. WE SAW NO CHANGE IN TISSUE. NO CHANGE ON THE COMPUTER SCREEN UNDER TOTAL ENERGY USED. NO GREEN LIGHT IN THE FIBER. WE CHANGED THE DURATION FROM .5 SECONDS TO 1 SECOND AND THEN TO CONTINUOUS WITH NO CHANGE IN THE LASER'S FUNCTIONING. THE DOCTOR WAS AWARE AT THIS POINT THAT THE LASER WAS NOT WORKING AND RN CALLED BIOMED. THE GE REP WAS CALLED FROM THE ROOM AND THE RN INFORMED HIM WHAT WAS HAPPENING WITH THE LASER. HE SAID HE WOULD BE IN TODAY TO LOOK AT THE LASER. RN INFORMED STAFF BECAUSE THEY WERE WAITING FOR THE KTP LASER FOR THEIR 9 AM KTP LASER CASE. RNTOOK THE LASER DOWN TO BIOMED, INFORMED THEM OF CONVERSATION WITH THE REP AND CALLED IN A WORK ORDER. RN INFORMED OUR MANAGER. RN ALSO INFORMED THE SCHEDULERS THAT THE LASER WAS DOWN UNTIL THE REP. COMES IN TO SEE IT AND IF THEY WANT TO BOARD A CASE TO CALL AND SEE IF IT IS WORKING. SPOKE WITH THE PATIENT'S MOTHER AND FATHER AFTER THE CASE, ALSO HAD THE CHIEF OF PEDIATRIC ENT SPEAK WITH THE FAMILY AS WELL TO REASSURE THE FAMILY THAT THEIR CHILD'S CASE WAS HANDLED APPROPRIATELY. THE GE SPECIALIST WAS CALLED IN - FOUND A LOOSE IC CHIP ON THE MAIN BOARD - PULLED OUT CHIPS AND RESEATED THEM. UNPLUGGED ALL WIRE CONNECTIONS AND RESEATED THOSE AS WELL. ENSURED A GOOD CONNECTION, AND LASER IS NOW WORKING FINE. ALSO REPLACED THE COOLANT AND WATER FILTERS. RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERSCOPE LASER, SURGICAL, KTP/YAG GEX AMERICAN MEDICAL SYSTEMS 813 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO