BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFLEX LITHOTRIPSY FIBER

    MDR report key: 2800947 · Received October 18, 2012

    Report

    Report Number
    2937094-2012-01063
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER (END) BROKE DURING THE PROCEDURE AND NEEDED TO BE RETRIEVED. THE DETACHED PIECE WAS REMOVED FROM THE KIDNEY USING AN ALTERNATIVE TOOL. NO PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLEX LITHOTRIPSY FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS S-LLF273TG 2122A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STONELIGHT SURGICAL LASER SYSTEM| ACCESSORIES