BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2802366 · Received October 19, 2012

    Report

    Report Number
    2937094-2012-01135
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 19, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A CLINICAL STUDY PT HAD A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE ON (B)(6) 2012. TWO DAYS POST PROCEDURE, THE PT PRESENTED WITH STRONG BLOODY URINE, ONSET DATE (B)(6) 2012. FLUSHING CATHETERS WERE USED. (B)(6) 2012, BLOOD COAGULATION HEMOSTASIS WAS PERFORMED. RESOLVED (B)(6) 2012. PROLONGED HOSP STAY (4 DAYS); DISCHARGED FROM HOSP (B)(6) 2012. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R ACCESSORIES| GREENLIGHT XPS LASER SYSTEM