MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC; INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE

Model Number	72-00322-0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 12/16/2025 nti was made aware of an alleged event in which a "physician aimed ehl at the stone, it broke the stone but came in contact with the cystic duct causing a bleed".Nti requested additional information about the probe used but no further information was avaliable from the customer.Nor-(b)(4) rev t.Was reviewed.Risk id 4.8(a) the risk analysis considers the risk of bleeding and clinical evaluation (nor-(b)(4) rev h) determines the benefits of lithotripsy outweigh the risks.The instructions for use (nor-(b)(4) rev c) has a warning which states "do not press the distal tip of the probe against tissue.Tissue damage, including perforation or thermal injury can result." a secondary warning is also listed, "improper use of the ehl probe could result in vessel perforation followed by bleeding and possible infection.Other complications such as vessel strictures resulting from edema and occlusions created by stone debris are also potential complications of ehl." as the single use device was not returned, it is hard to determine what led to the perferation, however, based on the customer description, it is possible the probe tip made contact with tissue resulting in injury.No additional information was provided regarding prolonged injury, or additional hospital intervention.In the past three years, nti has identified one other perforation/ tissue injury.If additional information is provided, a follow up report will be submitted.
Event or Problem Description
On (b)(6) 2025 nti recieved a complaint where the customer reported "physician aimed ehl at the stone, it broke the stone but came in contact with the cystic duct causing a bleed." the device was not returned to nti for further evaluation.

• Brand Name: AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
• Common Device Name: INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: jerry briggs ; 1591 scottsdale court; elgin, IL 60123
• MDR Report Key: 24026974
• Report Number: 0001450997-2026-00001
• Device Sequence Number: 13045589
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown