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

Model Number	72-00275-0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the servicing of a device for "an unknown fault", it was identified that the high voltage output wire to the resistor was disconnected.
Additional Manufacturer Narrative
During the service evaluation of the subject device there was substantial damage noted to the high voltage printed circuit board.The 50k ohm resistor was found unsecured within the device and one of the wires from the transformer to the resistor was disconnected.It is currently unknown if this damage was present in the field or if additional damage occurred during shipment back to nti.There was also cracking noted on the overlay and scuffs on the outside cover which indicate the device could have been abused.This malfunction report is being filed as the disconnection of the wire from the resistor to the transformer constitutes an increased risk of potential shock if the disconnected wire were to come into contact with the metal housing.The device history record review was performed for (b)(4) under complaint (b)(4).The device history record for (b)(4) from december of 2017 ((b)(4) 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 second instance of a wire on the secondary side of the hv output transformer breaking and compromising the isolation protection.Any additional findings will be updated via a follow-up report.

• Brand Name: AUTOLITH TOUCH
• Common Device Name: LITHOTRIPTOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 12456570
• Report Number: 0001450997-2021-00005
• Device Sequence Number: 5361033
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: No Information
• Device Model Number: 72-00275-0
• Device Catalogue Number: M005466800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1