BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2571426 · Received May 7, 2012

    Report

    Report Number
    2937094-2012-00403
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 13, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENTS FIBER AND CAP ARE ASSOCIATED WITH THE DEVICE BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED INSIDE THE PT AT 9,433 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THE METHOD OF CAP RETRIEVAL WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT NO PART OF THE DEVICE WAS LEFT INSIDE THE PT. IT WAS REPORTED THAT THE PT TOLERATED THE PROCEDURE WITH NO PROBLEMS AND THAT THERE WAS NO PT INJURY. THE PROCEDURE HAD BEEN INITIATED WITH A DIFFERENT FIBER, WHICH WAS ALSO REPORTED (REFERENCE MFR REPORT NUMBER 2937094-2012-00402.)

    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 139H

    Patients

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