BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9FR STERILE PROBE

    MDR report key: 541494 · Received March 30, 2004

    Report

    Report Number
    1218764-2004-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2004
    Date of Event
    February 5, 2004
    Report Date
    March 29, 2004
    Manufacturer
    ACMI STAMFORD
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE E-1F EHL PROBE ON A STONE AT 120 "HARD" SETTING ON AEH-2 LITHOTRIPSY SYSTEM, WHEN PT JUMPED. ANESTHESIA ALERTED THE SURGEON, WHO THEN CHANGED PROBES. REMAINING CASE WENT FINE. THERE IS NO PT INJURY. CUSTOMER THOUGHT PROBE MIGHT BE DEFECTIVE, CUSTOMER SAW BLACK SPOTS IN THE FOV RIGHT AFTER INCIDENT. ACMI REP EXPLAINED THAT IF THE DOCTOR HAD THE E-1F PROBE TOO CLOSE TO THE DISTAL TIP OF THE URETEROSCOPE THAT THIS COULD CAUSE AN ARC BACK THROUGH THE SCOPE AND AFFECT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9FR STERILE PROBE ELECTROHYDRAULIC LITHOTRIPSY PROBE FFK ACMI STAMFORD E-1F 1128303E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN