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U.S. Department of Health and Human Services

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

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NORTHGATE TECHNOLOGIES, INC AUTOLITH TOUCH LITHOTRIPTOR Back to Search Results
Model Number 72-00275-0
Device Problems Electrical /Electronic Property Problem (1198); Arcing of Electrodes (2289)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
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 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.
 
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Brand NameAUTOLITH TOUCH
Type of DeviceLITHOTRIPTOR
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 Key12345816
MDR Text Key267728406
Report Number0001450997-2021-00004
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
PMA/PMN Number
K130368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Repair
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number72-00275-0
Device Catalogue NumberM005466800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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