BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2222872 · Received August 10, 2011

    Report

    Report Number
    2937094-2011-01637
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AMERICAN MEDICAL SYSTEMS HAS CONTACTED THE PHYSICIAN IN AN ATTEMPT TO GAIN ADDITIONAL DETAILS ABOUT THE EVENT, THE STATUS OF THE PT AND THE AVAILABILITY AND IDENTIFICATION INFORMATION OF THE PRODUCT. AT THIS TIME THE CONCLUSION IS UNKNOWN REGARDING THE ROOT CAUSE OF THE PROBLEM AND THE ACTIONS TAKEN AS THE INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE, THAT DURING A CONVERSATION WITH THE PHYSICIAN, THE PHYSICIAN ALLUDED TO A RECENT INCIDENT INVOLVING DAMAGE TO AN ANGLED DELIVERY DEVICE (ADD) FIBER. THIS INCIDENT POSSIBLY RESULTED IN AN END-FIRING SITUATION OF THE FIBER AND BLADDER PERFORATION OF THE PT'S BLADDER. NO FURTHER DETAILS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other