BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2608266 · Received June 5, 2012

    Report

    Report Number
    2937094-2012-00545
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 17, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    THE CUSTOMER REPORTED THAT THE SIDE-FIRING FIBER FORWARD FIRED AND WAS DAMAGED AT THE TIP AT 12, 874 JOULES DURING PROSTATE VAPORIZATION. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. IT WAS REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2090 026H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYSTEM & ACCESSORIES