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

Model Number M005466800

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021, northgate technologies, inc was made aware of an alleged malfunction of a capital equipment device from distributor (b)(4) corporation on a complaint received against a disposable device used with the capital equipment device.The serial number and catalog number associated with the capital equipment are unknown however if the disposable was successfully used with the device the model of the device is either the 9-202-00 or the specifically branded model for the customer under 72-00275-0, therefore this report is being filed under 72-00275-0 given the information provided thus far.The reporter indicated in the complaint description, ".We have had several issues with our autolith involving fuses blowing during procedures.This happened again earlier this week.We had biomed involved during the procedure, which significantly lengthened the procedure and anesthesia time.The patient ultimately suffered a procedural complication that is requiring extended hospitalization." nti has made several attempts to get additional information on the device and patient status as well as request the device be returned for evaluation; however, to date no further information regarding the "patient complication", location of the device, nor other information related to the complaint event have been received by the manufacturer.This event is being reported to the fda with the information provided given that there is an allegation of a device malfunction that lead to a "significantly lengthened the procedure and anesthesia time" and "a procedural complication that is requiring extended hospitalization" per 21 cfr 803.The device history record could not be performed at this time as the serial number to the device is unknown.The nor-doc-(b)(4) risk analysis was reviewed.Given that the complaint stated that the device is "quite old" the risk assessment was reviewed understanding that age of the device could have impacted the complaint event.Line item 7.6.4 discusses loss of mechanical integrity causing the device to not perform to specification due to mechanical degradation with age.The hazards reference 7.6.3 for lack of adequate determination of end of device life.Line item 7.6.3.C refers to the delay in a procedure due to the device being used close to / beyond the expected lifetime of the device.The weighted severy is a 1 (negligible; minor discomfort or pain, no permanent impairment) and the occurence rate is a 2 (remote; very unlikely to happen) which results in an overall risk level score of 2 (no further action required / acceptable risk).A clinical evaluation was performed per nor-doc-cer-0002 which proved the benefits outweigh the risks.Any additional findings will be updated via a follow-up report.

Event Description

Northgate technologies, inc was made aware of an alleged issue on an autolith device on (b)(6) 2021, "we have had several issues with our autolith involving fuses blowing during procedures.This happened again earlier this week.We had biomed involved during the procedure, which significantly lengthened the procedure and anesthesia time.The patient ultimately suffered a procedural complication that is requiring extended hospitalization.".

• Brand Name: AUTOLITH TOUCH
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES, INC; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 12530863
• MDR Text Key: 280698435
• Report Number: 0001450997-2021-00007
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 00817183020493
• UDI-Public: 00817183020493
• Combination Product (y/n): N
• PMA/PMN Number: K130368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M005466800
• Device Catalogue Number: 72-00275-0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other