BEUDAMED
    FDA Adverse Event Summary report: N

    GREENLIGHT HPS

    MDR report key: 1662721 · Received April 15, 2010

    Report

    Report Number
    2937094-2010-00003
    Date Received
    April 15, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 19, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AMS CLINICAL TRAINER WAS PRESENT DURING THE CASE. SHE STATED THAT THE BLADDER TEAR WAS SUTURED. OUR CLINICAL TRAINER HAS INDICATED THAT THE STORZ LASER CYSTOSCOPE USED IN THE CASE APPEARED TO HAVE AN OUTFLOW GREATER THAN THE INFLOW. THIS RESULTS IN THE BLADDER BEING SUCKED TOWARDS THE PROSTATE. THIS WOULD THEN HAVE THE POTENTIAL OF LASING THE BLADDER. THE REGULATORY DEPARTMENT AT STORZ WAS CONTACTED AND RELAYED THAT THERE HAD BEEN NO COMPLAINTS OF THIS TYPE WITH THIS CYSTOSCOPE. (LASER CYSTOSCOPE-URETHROSCOPE SHEATH, P/N 27026 V). AMS CUSTOMER SERVICE ENGINEER VISITED THE SITE TO PERFORM A QUALITY INSPECTION ON THE LASER. THERE WAS NO PROBLEM FOUND WITH THE LASER, THE SYSTEM MET ALL MFG SPECIFICATIONS. F/U BY AMS CLINICAL TRAINER FOUND THE PT WAS FINE. THE SAME LASER AND INSTRUMENTATION WAS USED AGAIN BY 2 DIFFERENT PHYSICIANS WITH NO PROBLEMS. THE FIBERS USED IN THIS CASE ARE NOT AVAILABLE FOR EVAL. AMS IS PURSUING DOCTOR(S) OPINION AS TO IF OR HOW THE STORZ DEVICE CONTRIBUTED TO THE EVENT. THIS INFO WILL BE PROVIDED IN A F/U MEDWATCH REPORT.

    Description of Event or Problem · 1

    AMERICAN MEDICAL SYSTEMS' CLINICAL TRAINER FOR LASER THERAPIES IN AMS (B)(4) REPORTED THAT DURING A GREENLIGHT PVP (PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE) CASE THERE WAS AN ADVERSE EVENT. A BLADDER RUPTURE WAS NOTICED AT THE END OF THE CASE. A LAPAROTOMY WAS PERFORMED. A 3CM TEAR WAS FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention