BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2897036 · Received October 18, 2012

    Report

    Report Number
    2937094-2012-01039
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 17, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS A COPY OF THE USER REPORT WHICH WAS RECEIVED (B)(4) 2012 BY (B)(6). HOWEVER, THE USER'S REPORT NUMBER WAS NOT PROVIDED AND HAS NOT BEEN ABLE TO BE OBTAINED FROM THE CUSTOMER. ADDITIONAL INFORMATION FROM THE VOLUNTARY REPORT: BRAND NAME: GREENLIGHT PHS BPH FIBER OPTIC, COMMON DEVICE NAME: LASER FIBER, LOT #10-2090-210H, (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER (CAP) TIP DETACHED INSIDE OF THE PATIENT AT 140,210 JOULES INTO THE CASE. THE FIBER TIP WAS RETRIEVED. THE FIBER WAS REPLACED WITH A SECOND FIBER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. WHILE THE SURGEON WAS CREATING A GROOVE UTILIZING THE LASER FIBER, THE TIP OF THE LASER FIBER MELTED AND POPPED. THE FIBER WAS WITHDRAWN ALONG WITH THE TIP WHICH WAS EASILY REMOVED. A NEW FIBER WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 210H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GREENLIGHT HPS LASER SYSTEMS AND ACCESSORIES