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

Model Number 72-00275-0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A device used in non-clinical demonstrations with no related complaints was returned from the field for preventative maintenance.During preventative maintenance it is noted the insulated wire from the high voltage transformer is disconnected or found broken from the printer circuit board (loose wire) within the unit.

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).With the hv wire disconnected from the resistor, the unit will not be able to function as intended since a connected probe requires both wires to be connected to fire.However, there is a potential for electrical shock if the disconnected wire touches the metal case and if someone happens to make physical contact with the device or the patient while shots are being fired.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 issue (b)(4).Based on description of the complaint, the device was in working order at customer site and it was found damaged when received in house for repair.The device was returned in pelican case (non-validated shipping configuration) and there was some damage on the outer case of the returned unit.This indicates that the damage noted was highly likely to have occurred transit.Whenever the unit experiences excessive shock, the resistor can become loose from hv pcb and hv wire can become detached from pcb.There was no evidence of arcing inside the device which means the hv wire was not touching the outer case during shot firing.The device history record for 21824fba from june of 2017 (mo 12729) 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.Nor-doc-dra-0025 risk analysis was reviewed.Risk id 7.3.5 (a) refers to accidental mechanical damage with a potential hazard of patient or user injury by a damaged device.The potential hazard is delay in surgical procedure due to the machine not operating.The risk level post mitigation is an n which makes this an acceptable risk.There is an indication in the manual stating "be sure to inspect the autolith® touch unit and any accessories for proper operation before each use.If the unit is found to be defective or damaged, it should be returned to the manufacturer or qualified service personnel for inspection and repair." a clinical evaluation was performed per nor-doc-cer-0002 which proved the benefits of lithotripsy outweigh the risks.Nor-doc-dra-0025 risk analysis, risk id 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 nor-doc-cer-0002 which proved the benefits of lithotripsy outweigh the risks.If further information were to become available, a follow-up report would be submitted.

• Brand Name: AUTOLITH TOUCH
• Type of Device: 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: 16244447
• MDR Text Key: 309152245
• Report Number: 0001450997-2023-00001
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 00817183020493
• UDI-Public: 00817183020493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/06/2023

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: 10/06/2022
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1