MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. NEBULAE I; INSUFFLATOR

Model Number	7-650-00
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insufflator, nti part number 7-650-00; serial number (b)(4) arrived at nti on 7/01/20 from (b)(4) distributor (b)(4).The device and complaint were evaluated under nti capa (b)(4).During engineering's investigation the device was set up to an abdomen simulator with the settings as indicated in the complaint description.The unit functioned as expected under normal conditions.Further information about the incident was requested but no response has been received to date.Since details leading up to the incident and duration of the over insufflation were not provided it is difficult to determine the root cause.Possible root cause may be due to the smoke evacuator being too close to the trocar where tap was connected creating a negative pressure causing the continuous insufflation (which stabilized at 20 mmhg).It is also possible that some restriction existed at the time causing a temporary over insufflation.If further information is received from the customer that may help to identify the root cause, the capa may be reopened for further investigation.The device history record for 93152kcf from november of 2018 (manufacturing order (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.Any additional findings will be updated via a follow-up report.
Event or Problem Description
On 06/10/20, northgate technologies was made aware of an alleged issue with an insufflator from distributor (b)(4) in (b)(4) where it was alleged, "during use, insufflation by nebulae i didn't stop and the patient's abdomen swelled.Nebulae i was set at pressure 10mmhg and 25lpm with a smoke evacuator.Physician immediately vented gas from a port and used another unit after that.There was no adverse event.After that, our engineer serviced and did the repeatability test.But nothing abnormal was found on the unit".

• Brand Name: NEBULAE I
• Common Device Name: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin, il
• MDR Report Key: 10348038
• Report Number: 0001450997-2020-00005
• Device Sequence Number: 3484339
• Product Code: HIF
• UDI-Device Identifier: 00817183020219
• UDI-Public: 00817183020219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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
• Operator of Device: Health Professional
• Device Model Number: 7-650-00
• Device Catalogue Number: 7-650-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1