BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232333 · Received January 4, 2013

    Report

    Report Number
    3004378299-2012-00035
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 4, 2013
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO THE OPTIC FIBER FOR LASER DELIVERY. THIS OPTICAL FIBER IS NOT MANUFACTURED BY (B)(4). IN DATE (B)(4) 2013, WE SEND THE DAMAGED OPTICAL FIBER TO THE CORRECT MANUFACTURER: LEONI FIBER OPTICS. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    WHILE COVERING A QUANTA LASER OF THE PROSTATE FOR DR. (B)(6) (THIRD OF THE DAY) USING THE OUT QUANTA LASER SN: (B)(4). I ENCOUNTERED AN ISSUE WITH THE FIRST FIBER THAT WE USED FOR THE PROCEDURE, IT WOULD NOT RESIST AND PROVIDE FIBER INFORMATION SO I REPLACED IT WITH A NEW FIBER (OBM00136 800UM BARE CORE SURGICAL OPTICAL FIBER LOT/SERIAL #(B)(4)). THIS WAS A NEW FIBER THAT WAS STILL IN THE STERILE PACKAGING. ONCE CONNECTED IT PROVIDED THE FIBER INFORMATION AND SHOWED THAT THIS WAS THE FIRST USE (1/11). THE LASER WAS SET TO 150 WATTS AND I ACTIVATED THE LASER AND TOLD DOCTOR HE COULD BEGIN. IMMEDIATELY AS HE PRESSED THE FOOT SWITCH TO ACTIVATE THE LASER, THERE WAS A LOUD POP AND THE FIBER DISCONNECTED FORM THE SMA CONNECTOR. THIS WAS ACCOMPANIED WITH A FLASH AND A FLAME (2-3 INCHES) FROM THE CONNECTOR. I IMMEDIATELY INSTRUCTED DOCTOR TO RELEASE THE FOOT SWITCH AS I PUT THE LASER IN STANDBY MODE. I REACHED DOWN TO FEEL THE SMA CONNECTOR ( IT WAS COOL TO THE TOUCH) THEN DISCONNECTED THE SMA CONNECTOR AND VISUALLY INSPECTED THE PORT WHERE THE FIBER CONNECTS (THERE APPEARED TO BE NO DAMAGE TO THE PORT OR THE LASER UNIT), COLLECTED THE FIBER AND PLACED THEM BOTH INSIDE A BAG TO SEND BACK TO THE HOME OFFICE FOR INSPECTIONS. I OPENED ANOTHER NEW FIBER (SAME LOT/SERIAL #) CONNECTED IT TO THE UNIT AND THE CASE WAS PERFORMED WITHOUT FURTHER INCIDENT. DOCTOR INDICATED THAT WHEN HE ACTIVATED THE LASER WITH THE FIBER THAT DISCONNECTED HE HAD BEEN IN CLOSE PROXIMITY TO A BLADDER STONE AND WONDERED IF THAT MAY HAVE CAUSED THE ISSUE. I TOLD HIM THAT I DID NOT THINK SO BUT THAT I WAS NOT SURE AND THAT I WOULD BE SENDING THE FIBER IN FOR INSPECTION. I REPORTED THE ISSUE TO (B)(4) WHO PUT ME IN TOUCH WITH (B)(4). I EXPLAINED THE ISSUE WITH(B)(4), HE INSTRUCTED TO TEST THE LASER THE FOLLOWING MORNING BEFORE MY FIRST CASE TO MAKE SURE THINGS WERE OPERATING NORMALLY. I TEST FIRED THE LASER AT 6:15AM ON (B)(6) 2012, FOR OVER 2 MIN 30 SEC, FOR A TOTAL OF JUST OVER 20,000 JOULES. THE LASER PERFORMED THE TEST WITHOUT ANY ISSUES AND AS A RESULT WAS USED TO COMPLETE 2 PROCEDURES THAT DAY (BOTH WITHOUT ANY ISSUES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6441 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 150

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR