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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance of the device at northgate technologies, inc; it was noted in service evaluation the insulated wire from the high voltage transformer was disconnected from the high voltage printed circuit board (hv pcb).There was no evidence of arcing within the unit (metal housing) or that the unit was fired with the disconnected "broken" wire from the high voltage board.It is currently unknown if this damage was present in the field or occurred in transit.This report is being filed as a malfunction because the disconnection of the wire from the transformer to the hv pcb constitutes an increased risk of potential shock if the disconnected wire were to come into contact with the metal housing.The device was investigated under capa (b)(4).There are no burn marks found inside the cover which supports that the unit has not been discharged after the high voltage wire broke from the high voltage board.It is unclear at this time how the hv wire became disconnected from the hv pcb.A possible root cause could be that this occurred during a cover removal and re-installation process of the unit at the user facility and the insulated wire from the high voltage transformer to the pcb was either accidentally pulled or yanked.Warnings have been provided in the operator's manual that "the unit should not be opened except by a qualified service person.Tampering by unqualified persons can damage the unit and void the warranty".The operators manual indicates the dielectric and leakage testing has to be performed annually on devices.This device would fail that testing with the wire disconnected.The device history record for 22963edc from may of 2019 ((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 third instance of a wire on the secondary side of the hv output transformer breaking and compromising the isolation protection.The (b)(4) risk analysis was reviewed.Line item 7.3.5 discuss accidental mechanical damage with a potential hazard of a delay in procedure or possibly injury.In the case of this complaint the most likely occurrence would be 7.3.5 (a) a delay in the surgical procedure.This has an occurrence rate of a 2 (remote, very unlikely to happen) and a severity of a 1 (negligible, minor discomfort or pain, no permanent impairment), which corresponded to an acceptable risk with no further mitigation needed.Based on the nature of the failure observed given that the hv wire was disconnected, there is an increased risk of shock (indicated below).The (b)(4) section 7.1.1(a) addresses, "electricity - possible shock to patient and/or user due to electric shock" with the possible hazard identified as "break down of insulation on internal generator wires could cause electric shock".The mitigation is that the device was evaluated and passed iec 60601-1 safety testing.The severity is identified as a 5 (potential death) with a likelihood of severity of a 1 (incredible).The risk of death, or serious injury is considered less than remote.A clinical evaluation was performed per (b)(4) which proved the benefits of lithotripsy outweigh the risks.If further information were to become available, a follow-up report would be submitted.
Event or Problem Description
During the preventative maintenance of the device at northgate technologies, inc, it was identified in service evaluation that the insulated wire from the high voltage transformer was disconnected (wire broken) from the high voltage pcb within the unit.

• Brand Name: AUTOLITH TOUCH
• Common Device Name: LITHOTRIPTOR
• 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: 12961894
• Report Number: 0001450997-2021-00010
• Device Sequence Number: 13901397
• Product Code: FFK
• UDI-Device Identifier: 00817183020493
• UDI-Public: 00817183020493
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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
• Device Model Number: 72-00275-0
• Device Catalogue Number: M005466800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown