BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3864371 · Received June 10, 2014

    Report

    Report Number
    2937094-2014-00476
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 15, 2014
    Report Date
    May 17, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A GREENLIGHT PROCEDURE ON (B)(6) 2014. PRIOR TO THE PROCEDURE: A CYSTOSCOPY SHOWED "INFLAMMATION OF BLADDER". REPORTEDLY, THE GREENLIGHT PROCEDURE WAS 41 MINUTES AND "AN EXCESSIVE AMOUNT OF LASER ENERGY WAS USED". IMMEDIATELY POST OP, THE PATIENT REMAINED IN THE SURGICAL AREA. "I WAS IN AND OUT OF CONSCIOUSNESS AND BLEEDING". THE "SURGICAL NOTES SAY I PULLED ON THE CATHETER TWICE, BUT I DON'T REMEMBER DOING THIS; CATHETER SIZE 26". "NO BLOOD COUNT OR CBC WAS PERFORMED". AN AMBULANCE WAS DISPATCHED AND TOOK PATIENT TO THE HOSPITAL. AT 10PM AT NIGHT, HE WAS TAKEN FOR CYSTOSCOPY AND CAUTERIZED FOR BLEEDING. WAS IN ICU FOR 5 DAYS; 14 UNITS OF BLOOD GIVEN. HGB WAS 17 AT START OF GREENLIGHT PROCEDURE AND WENT DOWN TO HGB OF 6.5. WAS ON "PRESSORS" IN ICU. NOT ABLE TO WORK OR TRAVEL. IS SEEING A RECONSTRUCTIVE UROLOGIST AT UCSD. HAS URETHRAL STRICTURE AND WILL NEED URETHROPLASTY. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    THIS PATIENT CONTACTED AMS AND FURTHER COMMUNICATED HIS CONCERNS WITH HIS SURGERY. "I WAS NEAR DEATH FROM THE LASER". "THERE WAS A LOT OF BLOOD BEING EMPTIED FROM THE FOLEY BAG." "THERE WAS NO BLOOD TEST DONE AT TIME OF SURGERY AND I WAS IN HEMORRHAGIC SHOCK IN THE ER AND THEY PUT ME ON PRESSORS IN ORDER TO STOP THE BLEEDING". HE LEFT THE CALL WITH "I HAVE NOTHING FURTHER TO SAY". NO FURTHER INFORMATION WAS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341149 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| O| R