BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-IF ELECTROHYDRALIC LITHOTRIPTER PROBE

    MDR report key: 115335 · Received July 31, 1997

    Report

    Report Number
    115335
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    February 14, 1997
    Report Date
    February 19, 1997
    Manufacturer
    CIRCON ACMI
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SILVER TIP PORTION OF ELECTROHYDRALIC LITHOTRIPER (EHL) PROBE BROKE OFF IN PT DURING URETEROSCOPY. A DOUBLE J STENT WAS THEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-IF ELECTROHYDRALIC LITHOTRIPTER PROBE LITHOTHRIPTER PROBE (1.9 FR. DIAMETER-120 CM LENGTH) FFK CIRCON ACMI * HZ5075

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R