MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES, INC AUTOLITH TOUCH; LITHOTRIPTOR

Model Number	72-00275-0
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit and hv pcb are being investigated under capa (b)(4).This is being reported as a malfunction given that there was no patient or user impact to the noted issue and that based on the device evaluation the identified malfunction of the device if it were to recur could cause or contribute to serious injury or death per 21 cfr 803.The device history record for 21980ibb from september of 2017 (mo 12733) 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.This is the first issue nti is aware of where the spark gaps of a device would flash without being activated intentionally.Any additional findings will be updated via a follow-up report.
Event or Problem Description
Northgate technologies, inc.(nti) received a device for evaluation with an alleged complaint of "one of the ports is arcing electrical.", the complaint was coded by the distributor as no known impact or consequence to patient.Initial evaluation of the device indicated, the unit had signs of fluid invasion within the front panel and the unit was received with the fuses removed from the power module.The nature of the fluid contamination could not be determined.When the unit was powered on with new fuses, the display, spark gaps within the unit, and hv trigger board led were flashing involuntarily without connection to any external sources attached to the unit which is abnormal (the device is designed such that the spark gaps should only activate upon activation of the attached foot pedal accessory).There was no actual arcing or firing noted within the unit or outside the unit however given that the spark gaps were observed to be flashing this indicates that power could / was being transferred to the bulkhead connector without any activation.The device is designed with a bulkhead connector which is connected to a reusable extender cable which is then connected to disposable bipolar ehl probe to allow the energy propagation from the ehl generator to the tip of the probe.An extender cable nor probe were connected to the bulkhead while the display and spark gaps were flashing independently so transference of energy in this state was not confirmed.The hv trigger board seems to have been damaged with the fluid invasion.
Additional Manufacturer Narrative
The unit and hv pcb were investigated under capa 21048 and it was determined that the microprocessor on the hv pcb was not functioning correctly and possibly damaged causing the spark gaps to fire at power up.The cause of damage cannot be determined but most likely resulted from fluid ingression into the unit.No further determination of root cause can be made.

• Brand Name: AUTOLITH TOUCH
• Common Device Name: LITHOTRIPTOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES, INC; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 12345816
• Report Number: 0001450997-2021-00004
• Device Sequence Number: 17099129
• Product Code: FFK
• UDI-Device Identifier: 00817183020493
• UDI-Public: 00817183020493
• Combination Product (Y/N): N
• PMA/510(K) Number: K130368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: Other
• Device Model Number: 72-00275-0
• Device Catalogue Number: M005466800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1