BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEH-4 LITHOTRIPSY SYSTEM

    MDR report key: 8778707 · Received July 10, 2019

    Report

    Report Number
    0001450997-2019-00004
    Event Type
    Injury
    Date Received
    July 10, 2019
    Report Date
    July 10, 2019
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    PMA / PMN Number
    K923822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06/06/2019, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH A LITHOTRIPSY SYSTEM WHICH WAS MANUFACTURED FOR OEM CUSTOMER OLYMPUS SURGICAL TECHNOLOGIES AMERICA IN THE USA WHO REPORTED THE FOLLOWING, "THE END USER BURNED HERSELF DURING A CASE BUT NO PATIENT HARM." AFTER FURTHER FOLLOW UP THE FOLLOWING INFORMATION WAS RECEIVED "...DURING A ELECTROHYDRAULIC PROCEDURE [THE END USER'S] ARM WAS NEXT TO A CORD ON THE GENERATOR AND SHE WAS BURNED. THE [END USER] RECEIVED TREATMENT IN HOUSE FOR A MINOR BURN AND DOES NOT REQUIRE ADDITIONAL TREATMENTS." THE LITHOTRIPSY SYSTEM, NTI PART NUMBER 72-00167-0; SERIAL NUMBER (B)(4) WAS NOT PROVIDED TO NORTHGATE TECHNOLOGIES, INC. DESPITE MULTIPLE REQUESTS. THE UNIT WAS RETURNED TO AND EVALUATED BY OLYMPUS SURGICAL TECHNOLOGIES AMERICA. THE FOLLOWING INFORMATION IS FROM THEIR INVESTIGATION REPORT. "THE DEVICE WAS EVALUATED BY OLYMPUS ON 6/13/2019 AND BASED ON THE EVALUATION, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE PASSED THE ELECTRICAL SAFETY LEAKAGE TEST. IN ADDITION, FUNCTIONAL TEST TESTED NORMAL. THE CUSTOMER DID NOT SEND IN THE PROBE UNIT USED ALONG WITH THE DEVICE FOR EVALUATION." A DEVICE HISTORY RECORD REVIEW (DHR) WAS CONDUCTED BY NORTHGATE TECHNOLOGIES, INC. FOR THE DEVICE UNDER COMPLAINT (B)(4). THE DEVICE HISTORY RECORD FOR (B)(4) FROM JANUARY OF 2008 ((B)(4)) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED TO NTI FOR THIS DEVICE. ANY ADDITIONAL FINDINGS WILL BE UPDATED VIA A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON 06/11/2019, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH A LITHOTRIPSY SYSTEM WHICH WAS MANUFACTURED FOR OEM CUSTOMER OLYMPUS MEDICAL IN THE USA WHO REPORTED THE FOLLOWING, "THE END USER BURNED HERSELF DURING A CASE BUT NO PATIENT HARM." AFTER FURTHER FOLLOW UP THE FOLLOWING INFORMATION WAS RECEIVED "...DURING A ELECTROHYDRAULIC PROCEDURE [THE END USER'S] ARM WAS NEXT TO A CORD ON THE GENERATOR AND SHE WAS BURNED. THE [END USER] RECEIVED TREATMENT IN HOUSE FOR A MINOR BURN AND DOES NOT REQUIRE ADDITIONAL TREATMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572734 AEH-4 LITHOTRIPSY SYSTEM FFK NORTHGATE TECHNOLOGIES INC. 72-00167-0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention