BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROHYDRAULIC LITHOTRIPSY PROBE

    MDR report key: 541011 · Received March 26, 2004

    Report

    Report Number
    1418479-2004-00010
    Event Type
    Malfunction
    Date Received
    March 26, 2004
    Date of Event
    February 10, 2004
    Report Date
    March 4, 2004
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE METAL TIP OF AN ELECTROHYDRAYULIC LITHOTRIPSY PROBE CAME OF IN A PT'S URETER DURING STONE REMOVAL SURGERY. THE LOOSE TIP WAS RETRIEVED. NO CONSEQUENCE TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROHYDRAULIC LITHOTRIPSY PROBE ELECTROHYDRAULIC LITHOTRIPSY PROBE FFK RICHARD WOLF MEDICAL INSTRUMENTS 2280.421 131971

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR