BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 17368180 · Received July 20, 2023

    Report

    Report Number
    0001450997-2023-00003
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 20, 2023
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 20JUN2023 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT THAT OCCURRED IN MEXICO. BASED ON THE INFORMATION PROVIDED THROUGH (B)(6) 2023, THERE WAS NO ADVERSE EVENT TO THE PATIENT, AND THE ADVERSE EVENT EXPERIENCED BY THE ANESTHESIOLOGIST WAS MINOR. THIS EVENT IS BEING REPORTED AS A DEVICE MALFUNCTION GIVEN THAT THE INJURY REPORTED DID NOT MEET THE CRITERIA FOR A SERIOUS INJURY PER 21 CFR 803 (AN ADVERSE EVENT THAT IS LIFE-THREATENING; RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.) BUT THE EVENT AS REPORTED REASONABLY SUGGESTS THAT THE DEVICE MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. ISSUE-2023-0028 WAS INITIATED TO DOCUMENT THE EVENT INVESTIGATION. THE DEVICE HISTORY RECORD FOR 16830 FROM FEBRUARY OF 2023 (MO 16830) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS LOGGED FOR THIS LOT OF PRODUCT. THE DEVICE HISTORY RECORD FOR THE CAPITAL EQUIPMENT USED IN THIS COMPLAINT (B)(4) FROM MARCH OF 2018 (MO 12836) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE HAS NOT BEEN RETURNED TO NTI FOR REPAIR / EVALUATION PREVIOUSLY. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED TO NTI FOR THIS DEVICE. PER ISSUE-2023-0028: THE COMPLAINT COULD NOT BE VERIFIED AS THE PROBE AND GENERATOR WERE NOT RETURNED BY THE HOSPITAL. THE PROBE IS DESIGNED SO THAT THE TWO WIRES THAT CARRY THE ELECTRIC CHARGE FROM THE CONNECTOR TO THE TIP ARE INSULATED BY THE POLYIMIDE MATERIAL AND FOR HALF THE PROBE THE POLYIMIDE IS REINFORCED BY THE "CLEAR" KYNAR MATERIAL FROM THE CONNECTOR END. SEVERAL ATTEMPTS WERE MADE TO GATHER MORE INFORMATION FROM THE CUSTOMER REGARDING THE EVENT AND THERE WERE NO RESPONSES. THE EHL PROBES UTILIZE A BIPOLAR DESIGN TO CREATE THE PRESSURE WAVES FOR STONE FRAGMENTATION. IN ORDER FOR PRESSURE WAVES TO FORM, ELECTRICAL CURRENT IS SENT THROUGH THE CENTER CONDUCTOR AND JUMPS TO THE GROUNDED TIP WHICH IS SOLDERED TO THE GROUND WIRE AND LEADS BACK TO THE GENERATOR. THE WORST-CASE SCENARIO (LARGEST) DISTANCE BETWEEN THE CENTER CONDUCTOR AND THE GROUNDED TIP IS 0.00275". FOR THE ELECTRICAL CURRENT TO JUMP TO A PATIENT AND SUBSEQUENTLY SHOCK A HEALTHCARE WORKER, THE PROBE TIP WOULD HAVE TO BE LESS THAN 0.00275" AWAY FROM THE TISSUE AND THE PATIENT WOULD NEED TO BE IN CONTACT WITH SOME GROUNDING DEVICE/PERSON THAT IS GROUNDED. WHEN THE PROBE IS THIS CLOSE TO THE TISSUE, THERE WOULD BE INCREASED BLEEDING AND BURNING OF THE TISSUE. IN ADDITION, IF THE CURRENT DID JUMP TO THE PATIENT, THE PERFORMING SURGEON WOULD NOTICE A CHANGE IN THE FUNCTIONALITY OF THE DEVICE AND DECREASED STONE FRAGMENTATION ABILITY. IF FURTHER INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. THE ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    ON 20JUN2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT " THE PHYSICIAN WAS PERFORMING EHL USING SPYGLASS DS AND AUTOLITH WITHOUT ANY PROBLEM. HOWEVER, AROUND 15-20 MIN INTO THE PROCEDURE, THE ANESTHESIOLOGIST COMPLAINED SAYING THAT SHE FELT AN ELECTRIC SHOCK AT THE PRECISE MOMENT WHEN AUTOLITH WAS SHOOT AND SHE TOUCHED THE PATIENT WITHOUT GLOVES. AFTER THAT THE AUTOLITH PROBE WAS WITHDRAWN AND THE SPYSCOPE STOPPED WORKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193898 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0 16830 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other