BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLITH TOUCH EHL PROBE

    MDR report key: 6965725 · Received October 20, 2017

    Report

    Report Number
    0001450997-2017-00002
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 18, 2017
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NTI WAS MADE AWARE OF AN ISSUE FROM CUSTOMER (B)(6) WHERE IT WAS ALLEGED THAT THE "PROBE WAS NOT BREAKING UP THE STONE". FURTHER INFORMATION WAS PROVIDED TO NORTHGATE IN THE COMPLAINT FOR "BURNING SMELL". THIS REPORT IS BEING FILED FOR THE "BURNING SMELL" ISSUE. THE COMPLAINT ORIGINATED FROM (B)(6) HOSPITAL. THE PROBE WAS RETURNED TO NORTHGATE TECHNOLOGIES WITH THE CONNECTOR DISCONNECTED, SO THE DEVICE COULD NOT BE ASSESSED FULLY FOR PROPER FUNCTION. THE PROBE HAD A KINK ADJACENT TO THE KYNAR SLEEVE, OF UNKNOWN ORIGIN. THE CONNECTOR WAS NOT CONNECTED TO THE PROBE AND SEEMS TO BE HAVE BEEN SEPARATED FROM THE REST OF THE PROBE. AFTER VIEWING THE PROBE UNDER THE MICROSCOPE, THERE SEEMED TO BE POSSIBLE EVIDENCE OF CHARRING AT THE SEPARATION OF THE PROBE FROM THE CONNECTOR. THE DISCOLORED PORTION UNDERNEATH THE KYNAR IS DUE TO LOCTITE (ADHESIVE USED DURING ASSEMBLY) AND NOT THE CHARRING. (B)(4). A DEVICE HISTORY REVIEW WAS PERFORMED, AND THE LOT PASSED WITH NO INDICATED FAILURES. PROBES ARE 100% VERIFIED BY ACTIVATING THE PROBE FOR 30 PULSES. PER SECTION 7.3.5 (E) OF THE RISK ASSESSMENT FOR AUTOLITH TOUCH/URO-TOUCH/BSC AUTOLITH TOUCH & ASSOCIATED EHL DISPOSABLE PROBES (NTI DOCUMENT NUMBER (B)(4)), "PROBE WIRES EXPOSED - BURN TO OPERATOR OR PATIENT". WHILE THE WIRES WERE NOT EXPOSED, A SHORT OF SOME KIND APPEARS TO HAVE OCCURRED AT THE CONNECTOR, AS EVIDENCED BY THE APPARENT CHARRING AT THE SEPARATION OF THE PROBE FROM THE CONNECTOR. PER THE OPERATOR'S MANUAL UNDER WARNINGS: "ELECTROHYDRAULIC LITHOTRIPTER PROBES ARE LIMITED LIFE, SINGLE USE DEVICES. IF ANY OF THE FOLLOWING CONDITIONS ARE NOTED, REGARDLESS OF THE "REPLACE PROBE" MESSAGE, STOP USING IMMEDIATELY AND USE A NEW PROBE: FIRING (OR ARCING) BEHIND THE TIP, EJECTION OF THE TIP OR INSULATION MATERIAL, ARCING ALONG THE WIRES OR INSIDE/OUTSIDE THE CONNECTOR." "!WARNING! DO NOT ATTEMPT TO REUSE A PROBE ONCE IT HAS BEEN USED PAST 100% OF ITS USEFUL LIFE."

    Description of Event or Problem · 1

    ON SEPTEMBER 21, 2017, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN EVENT IN WHICH IT WAS ALLEGED THAT DURING A PROCEDURE, "AUTOLITH FIBER FAILED TO WORK AFTER SEVERAL MINUTES OF TRYING TO BREAK UP A STONE ON MEDIUM POWER. BURNING SMELL NOTICED DURING THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743716 AUTOLITH TOUCH EHL PROBE BILIARY ELECTROHYDRAULIC LITHOTRIPTER PROBE FFK NORTHGATE TECHNOLOGIES INC. M00546620 BSC12771 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1