BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2801544 · Received October 18, 2012

    Report

    Report Number
    2937094-2012-01042
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    July 12, 2012
    Report Date
    September 18, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED. THE MFR ASSIGNED MODEL NUMBER 0010-2093 IS DESIGNATED FOR (B)(4) DISTRIBUTION. THIS REPORT IS BEING SUBMITTED AS THE MODEL 0010-2093 IS IDENTICAL IN DESIGN AND MFR TO THE COMMERCIALLY AVAILABLE MODEL 0010-2090 ANGLED DELIVERY DEVICE, GREENLIGHT (K062719).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 351, 920 JOULES DURING A PROSTATE PROCEDURE. THE PHYSICIAN WAS SATISFIED WITH THE PROCEDURE AND THEREFORE, THE CASE WAS CONSIDERED COMPLETE WITHOUT THE NEED FOR AN ADD'L FIBER. NO PT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMS 0010-2093 148J

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT HPS LASER SYSTEM| ACCESSORIES