BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2515454 · Received March 29, 2012

    Report

    Report Number
    2937094-2012-00321
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    November 28, 2011
    Report Date
    March 7, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 7,095 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THE PATIENT OUTCOME WAS REPORTED AS "OKAY". THE PROCEDURE HAD BEEN INITIATED WITH A DIFFERENT FIBER, WHICH WAS ALSO REPORTED (REFERENCE MFR REPORT NUMBER 2937094-2012-00320).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2090 117H

    Patients

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