BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3903333 · Received June 30, 2014

    Report

    Report Number
    2937094-2014-00559
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 21, 2012
    Report Date
    June 4, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT "UNDERWENT A SURGICAL PROCEDURE DESCRIBED AS "CYSTOSCOPY WITH TRANSURETHRAL VAPORIZATION OF PROSTATE". THE "PATIENT BECAME AWARE OF INCONTINENCE ON (B)(6), 2012 WHEN THE CATHETER FROM THE (B)(6), 2012 PROCEDURE WAS REMOVED". REPORTEDLY, THE PATIENT HAS EXPERIENCED "COMPLETE INCONTINENCE, LATER SEPSIS AND HOSPITALIZATION; HE NOW REQUIRES CORRECTIVE SURGERY TO PROVIDE AN ARTIFICIAL SPHINCTER". THERE HAVE BEEN "QUALITY OF LIFE CHANGES".NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379505 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R