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

Model Number	72-00322-0
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 northgate technologies, inc was made aware of an alleged event," the lithotyping probe is connected to the equipment, it is passed to the specialist to start the procedure and it is seen that it is not fracturing the stones, the doctor indicates that he feels something that is not right with the probe, 3 more shots were made and the probe makes a kind of short in the distal part, sparks came out of the part where the coating is located, immediately the procedure was stopped and the probe was changed." the health professional completed the procedure by using a different device of the same model type.No allegations of patient or user injury was reported from the event.On (b)(6) 2022 and (b)(6) 2022, nti send follow up questions to the customer to understand if there was a device malfunction.With the available information from the customer the probe fired from the distal end and is not deemed as a malfunction of the device to be reportable on (b)(6) 2022.The suspect device was returned on (b)(6) 2022 and in evaluation the device appeared to have malfunctioned.
Additional Manufacturer Narrative
This event is being reported as a device malfunction per 21 cfr 803 given that there were no serious injuries or adverse events reported but the evaluation as found reasonably suggests that the device malfunctioned and that the device or a similar device marketed by the manufacturer could cause or contribute to serious injury or death if the malfunction were to recur depending on the location of the malfunction and other contributing factors.The intial evaluation of the suspect device is captured under capa (b)(4).The suspect device was returned on (b)(6) 2022 and the device evaluation identified the probe malfunctioned.The probe connector was not attached to the length of the probe.The kynar protective sleeve was missing from the connector down the length of the probe.The separation of the connector and the length of the probe is first occurence.The wires are designed to carry the electric charge from the connector to the tip of the probe.All probes are test fired prior to release of product into the field and as indicated by the complaintant the device was fired by the end user.It is unknown how many shots were fired before the malfunction was noted.The device history record for bsc15607 from august 2021 (mo 15607) was reviewed and the lot passed all testing.No manufacturing deviations were noted.The nor-doc-dra-0025 risk analysis was reviewed.Section 7.3.5 (d) refers to "no spark due to damaged probe - procedure delayed" is the condition stated.Per the operator's manual on page 2 under warnings "to avoid procedural delays and possible incomplete stone fragmentation, please have two or more ehl probes available for each lithotripsy procedure." the risk of death or serious injury from the stated issue is remote.Section 7.3.5.(e) which refers to the risk of accidental mechanical damage resulting in injury to patient or operator from the damaged device (exposed probe wires) causing a burn.The mitigation of the risk is there is double insulated wiring and this type of failure would require multiple faults to occur.The overall severity post mitigation is 2 for minor (significant discomfort or pain, no permanent impairment) and a likelihood of 2 (remote; very unlikely to happen).A clinical evaluation was performed per nor-doc-cer-0002 which proved the benefits of lithotripsy outweigh the risks.If further information become available with capa investigation, a follow up report will be submitted.

• Brand Name: AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
• Common Device Name: INTRA-CORPOREAL ELECTROHYDRAULIC 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: todd gatto ; 1591 scottsdale court; elgin, IL 60123 ; 2248562250
• MDR Report Key: 14458838
• Report Number: 0001450997-2022-00005
• Device Sequence Number: 4570304
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (Y/N): N
• 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: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2024
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Device Lot Number: BSC15607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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