BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2935080 · Received January 14, 2013

    Report

    Report Number
    2937094-2013-00073
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, WITH THE PATIENT ON THE TABLE, THE LASER DEVICE RECEIVED ERRORS 210 AND 235. THE PHYSICIAN COULDN'T PROCEED WITH THE PROCEDURE. IT IS UNK HOW THE PHYSICIAN COMPLETED THE CASE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21222 GREENLIGHT HPS LASER SYSTEM POWERED SURGICAL LASER INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE

    Patients

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