BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3032793 · Received March 29, 2013

    Report

    Report Number
    2937094-2013-00364
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIRST SIDE-FIRING SURGICAL WAS OBSERVED TO BE FORWARD-FIRING AT 27,295 JOULES OF USE; THE CASE WAS CONTINUED USING A SECOND SURGICAL FIBER, WHICH WAS OBSERVED TO BE FORWARD-FIRING AT 123,735 JOULES OF USE. A THIRD FIBER WAS THEN ATTACHED, HOWEVER THE FIBER CARD WAS NOT READABLE BY THE SYSTEM (0 JOULES OF USE). THE CASE WAS COMPLETED BY TURP. THERE WAS NO REPORT OF INJURY. THIS REPORT IS FOR THE SECOND SURGICAL FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130715 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 10-2090 250H

    Patients

    Seq Age Sex Outcome Treatment
    1