BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEH-4 LITHOTRIPSY SYSTEM,110V

    MDR report key: 8732866 · Received June 25, 2019

    Report

    Report Number
    2951238-2019-00973
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    June 25, 2019
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    FFK
    PMA / PMN Number
    K923822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION OF THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE WITH NORMAL COSMETIC WEAR AND TEAR. NO PHYSICAL ANOMALIES OBSERVED ON THE UNIT. AN ELECTRICAL PATIENT SAFETY LEAKAGE TEST WAS CONDUCTED AND PASSED. UNIT TESTED AND PASSED ALL FUNCTIONAL TESTS. THE PROBE EXTENDER CABLE WAS RECEIVED WITHOUT THE PROBE UNIT. A TEST PROBE UNIT WAS USED FOR EVALUATION. WHEN THE PROBE EXTENDER CABLE AND PROBE UNIT IS CONNECTED TO THE AEH-4 LITHOTRIPSY SYSTEM, IT IS POSSIBLE FOR THE END USER TO GET SHOCKED IF IN CONTACT WITH THE PROBE TIP UPON ACTIVATION. NO DAMAGE OR ANOMALIES OBSERVED ON THE PROBE EXTENDER CABLE. BASED ON THE EVALUATION, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE USER MANUAL STATES ¿THIS DEVICE SHOULD BE OPERATED ONLY BY OR UNDER THE DIRECT SUPERVISION OF A PHYSICIAN EXPERIENCED IN ELECTROHYDRAULIC LITHOTRIPTER (EHL) PROCEDURES. THE USER SHOULD BE THOROUGHLY FAMILIAR WITH THE OPERATION OF THE EHL GENERATOR PRIOR TO USE."

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT THE END USER WAS BURNED DURING AN ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE. THE END USER'S ARM TOUCHED THE CABLE CONNECTED TO THE GENERATOR UNIT. THE END USER WAS TREATED IN IN-HOUSE FOR A MINOR BURN AND DOES NOT REQUIRED FURTHER TREATMENTS. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION RELATED TO THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525912 AEH-4 LITHOTRIPSY SYSTEM,110V AEH-4 LITHOTRIPSY SYSTEM FFK NORTHGATE TECHNOLOGIES, INC. AEH-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN PROBE