MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC.; AEH-4 LITHOTRIPSY SYSTEM

Model Number 72-00167-0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

On 06/06/2019, northgate technologies was made aware of an issue with a lithotripsy system which was manufactured for oem customer olympus surgical technologies america in the usa who reported the following, "the end user burned herself during a case but no patient harm." after further follow up the following information was received ".During a electrohydraulic procedure [the end user's] arm was next to a cord on the generator and she was burned.The [end user] received treatment in house for a minor burn and does not require additional treatments." the lithotripsy system, nti part number 72-00167-0; serial number (b)(4) was not provided to northgate technologies, inc.Despite multiple requests.The unit was returned to and evaluated by olympus surgical technologies america.The following information is from their investigation report."the device was evaluated by olympus on 6/13/2019 and based on the evaluation, the reported complaint could not be confirmed.The device passed the electrical safety leakage test.In addition, functional test tested normal.The customer did not send in the probe unit used along with the device for evaluation." a device history record review (dhr) was conducted by northgate technologies, inc.For the device under complaint (b)(4).The device history record for (b)(4) from january of 2008 ((b)(4)) was reviewed and the device passed all testing.Nothing out of the ordinary was noted.There have been no other complaints reported to nti for this device.Any additional findings will be updated via a follow-up report.

Event Description

On 06/11/2019, northgate technologies was made aware of an issue with a lithotripsy system which was manufactured for oem customer olympus medical in the usa who reported the following, "the end user burned herself during a case but no patient harm." after further follow up the following information was received ".During a electrohydraulic procedure [the end user's] arm was next to a cord on the generator and she was burned.The [end user] received treatment in house for a minor burn and does not require additional treatments.".

• Type of Device: AEH-4 LITHOTRIPSY SYSTEM
• 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: 8778707
• MDR Text Key: 150686371
• Report Number: 0001450997-2019-00004
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72-00167-0
• Device Catalogue Number: AEH-4
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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
• Patient Outcome(s): Required Intervention