BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX LITHOTRIPSY FIBER

    MDR report key: 2896625 · Received December 28, 2012

    Report

    Report Number
    2937094-2012-01355
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE EVIDENCE OF FIBER BREAKAGE IN THE BODY OF THE FIBER APPROXIMATELY 109 INCHES FROM THE CONNECTOR (THE FIBER HAS NOT SEPARATED) AND THE FIBER SHEATH SHOWS SIGNS OF BEING DAMAGED. THE FIBER TIP HAS A FRACTURE AND A PORTION OF THE FIBER TIP HAS CHIPPED OFF. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINE TO POSSIBLY BE DUE TO USER HANDLING AND/OR SURGICAL EQUIPMENT RELATED DAMAGE. AN ADDITIONAL FIBER WAS USED AND REPORTED UNDER MDR NUMBER 29374-2012-01354. THIS REPORT IS FOR THE SECOND FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER BROKE OFF INSIDE OF THE SCOPE DURING A PROCEDURE. A SECOND FIBER WAS USED AND ALSO BROKE OFF INSIDE OF THE SCOPE. REPORTEDLY, NO HARM TO PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLEX LITHOTRIPSY FIBER SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS S-LLF273TG 1431A

    Patients

    Seq Age Sex Outcome Treatment
    1 STONELIGHT LASER SYSTEM AND ACCESSORIES