BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3030211 · Received March 26, 2013

    Report

    Report Number
    2937094-2013-00373
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED DURING THE PROSTATE PROCEDURE. IT IS UNK IF THE DEVICE WAS INSIDE THE PT AT THE TIME OF THE DETACHMENT; HOWEVER, IT APPEARS IT MAY HAVE BEEN DURING USE. THE LOCATION OF THE CAP IS UNK; HOWEVER, THERE WAS NO REPORT OF THE DEVICE REMAINING INSIDE THE PT OR THAT CAP RETRIEVAL WAS PERFORMED. THE PHYSICIAN PERFORMED A TURP TO COMPLETE THE CASE. "NO INJURY TO PT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124203 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 245B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other