BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3061570 · Received April 11, 2013

    Report

    Report Number
    2937094-2013-00437
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED DURING THE PROSTATE PROCEDURE AT 183,493 JOULES. IT IS UNKNOWN IF THE DEVICE WAS INSIDE THE PATIENT AT THE TIME OF THE DETACHMENT, HOWEVER, IT APPEARS IT MAY HAVE BEEN DURING USE. THE LOCATION OF THE CAP IS UNKNOWN, HOWEVER, THERE WAS NO REPORT OF THE DEVICE REMAINING INSIDE THE PATIENT OR THAT CAP RETRIEVAL WAS PERFORMED. ADDITIONAL INFORMATION WAS NOT PROVIDED. "NO INJURY TO THE PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155545 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 250A

    Patients

    Seq Age Sex Outcome Treatment
    1