BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS

    MDR report key: 1712551 · Received June 3, 2010

    Report

    Report Number
    2937094-2010-00004
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 3, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE: UNKNOWN AT THIS TIME, AS IT WAS PROVIDED BY A MOBILIZER. THE DOCTOR TOOK PRECAUTIONS OF RELEASING THE PRESSURE ON THE OUTTAKE VALVE (AUTOMATIC FLUID PUMP) OVER 3 TIMES. THE PATIENT WAS ON A VENTILATOR ALL NIGHT. THE AUTOMATIC FLUID PUMP WAS SUPPLIED BY SURGICAL LASER SOLUTIONS. AMS FOLLOWED UP WITH THE RISK MANAGER AT THE FACILITY. SHE STATED THAT THE LASER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S TORN BLADDER. THE PATIENT IS FINE. THE RISK MANAGER DID NOT GIVE ANY FURTHER INFORMATION AS TO WHAT INTERVENTION MAY HAVE TAKEN PLACE SINCE THIS WAS NOT CAUSED OR CONTRIBUTED TO THE LASER. HOWEVER, THEIR INVESTIGATION WAS NOT COMPLETE, AND SHE STATED IF THEY DID FIND THAT OUR LASER CONTRIBUTED TO THE INCIDENT, SHE WOULD CALL US. NO INFORMATION WAS PROVIDED TO AMS CONCERNING THE AUTOMATIC FLUID PUMP. THE LASER DID NOT RETURN TO AMS NOR DID THE FACILITY REQUEST AN INSPECTION OF THE LASER. IF ANY FURTHER INFORMATION IS OBTAINED, AMS WILL FILE A FOLLOW UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO AN AMERICAN MEDICAL SYSTEMS REPRESENTATIVE THAT DURING A GREENLIGHT PVP (PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE) PROCEDURE, A PATIENT HAD A BLADDER TEAR. THE DOCTOR DID NOT BLAME THE HPS GREENLIGHT PROCEDURE BUT SATED, HE USED AN AUTOMATIC FLUID PUMP THAT IF NOT REGULATED CORRECTLY CAN CAUSE THE BLADDER TO FALL DOWN OVER THE PROSTATE AND MAKE IT DIFFICULT TO DIFFERENTIATE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O