BEUDAMED
    FDA Adverse Event Other Summary report: N

    GREENLIGHT HPS

    MDR report key: 1547266 · Received November 25, 2009

    Report

    Report Number
    2937094-2009-00005
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    April 10, 2009
    Report Date
    October 29, 2009
    Manufacturer
    AMS INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LASER DID NOT RETURN FOR EVAL NOR DID FACILITY OR DOCTOR REQUEST A CUSTOMER SERVICE ENGINEER TO CHECK THE LASER. NO MALFUNCTION WAS REPORTED. THIS IS A (B)(4). THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2009 AT (B)(6). THERE WERE NO PT PROBLEMS REPORTED AT THE TIME OF SURGERY. THE PT WAS ADMITTED TO THE HOSP ON (B)(6) FOR GROSS HEMATURIA AND CLOT RETENTION. THE FACILITY PERFORMED AN IMMEDIATE TURP PROCEDURE DUE TO LOW BLOOD COUNT AND THE PT WAS DISCHARGED IN STABLE CONDITION ON (B)(6). THE SERIOUS ADVERSE EVENT FORM HAS THE OUTCOME AS "RECOVERED". CLINICAL INFO: GROSS HEMATURIA AND CLOT RETENTION ARE RELATED, LOTS OF BLEEDING RESULTS IN CLOT FORMATION WHICH, WHEN THE CLOTS GET BIG ENOUGH, CAN GET LODGED IN THE URETHRA AND CAUSE URINARY RETENTION. THE TREATMENT CAN BE CATHETERIZATION WITH REMOVAL OF THE CLOT OR RE-OPERATION IF THERE IS CONCERNS ABOUT THE CONTINUE BLEEDING OR VOLUME REMOVAL. THE FACILITY OPTED TO DO A TURP TO REMOVE THE CLOT AND TREAT THE BLEEDER(S) CAUSING THE CLOTS. THE RATES OF THIS TYPE OF EVENT IS APPROXIMATELY LESS THAN 1%. OUR GREENLIGHT HPS OPERATOR'S MANUAL, P/N 010-0009, REV. D, LISTS BLEEDING UNDER POTENTIAL COMPLICATIONS AND RISKS. "BLEEDING: PTS' MAY EXPERIENCE BLEEDING AT THE SITE OF THE LASER THERAPY DURING OR AFTER LASER THERAPY. POST-TREATMENT HEMOGLOBIN AND HEMATOCRIT ARE RECOMMENDED TO ASSESS THE SEVERITY OF THE BLEEDING." UNDER PRECAUTIONS, REPORTED ADVERSE EVENTS INCLUDE "HEMATURIA" AND "URINARY RETENTION". THE TWO FIBERS USED IN THE CASE WERE RECEIVED AT AMS (B)(6) ON (B)(6), 2009 BUT WAS DETERMINED AS NOT A COMPLAINT AT THAT TIME. NO FAILURE ANALYSIS WAS NECESSARY AND FIBERS WERE SCRAPPED PER PROCEDURE. THE SERIOUS ADVERSE EVENT FORM WAS RECEIVED BY AMS (B)(6) ON (B)(6), 2009. THE SAE FORM WAS RECEIVED BY AMS (B)(6) ON (B)(6), 2009. IF ANY FURTHER INFO IS OBTAINED A F/U MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    (B)(4) REPORTED THE FOLLOWING: "THE PT WAS TAKEN TO THE (B)(6) HOSP EMERGENCY ON (B)(6) 2009 AND HOSPITALIZED DUE TO GROSS HEMATURIA AND CLOT RETENTION, FOLLOWING ONE MONTH OF HIS PVP PROCEDURE. DUE TO LOW BLOOD COUNT THE UROLOGIST AT BRANTFORD SITE DID AN IMMEDIATE TURP PROCEDURE AND PT DISCHARGED IN STABLE CONDITION (B)(6) 2009."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER GEX AMS INNOVATION CENTER - SILICON VALLEY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R