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	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is in the process of being returned for evaluation.The evaluation will be conducted under capa (b)(4).This report will be amended with those results when they are available.The device history record for (b)(4) from february of 2019 ((b)(4)) was reviewed and the device passed all testing.During initial manufacture the device was missing part of the print on the rear panel which required replacement of the rear panel.The device passed all inspections and fqc testing after the rework.The device was upgraded from rev g to rev j via (b)(4) on 10/1/19.The device passed all service and fqc inspections and testing after the upgrade.This device has been in the nti marketing pool since 10/2019 and has been loaned out 1 time.The device has not been returned to nti for repair / evaluation previously.There have been no other complaints reported to nti for this device.Based on the complaint description, it is believed that the device did not malfunction and that the overpressure condition was due to the excess scar tissue in the patient which created restrictions.Restrictions increase the risk of inaccurate distention pressures.After the overpressure of the abdomen was released and the scar tissue removed, the device was used to complete the procedure without further incident.The device was used in subsequent procedures without incident.
Event or Problem Description
On 12/12/19 nti was made aware of the following alleged event "description of the incident: patient had many laparoscopic surgery in the past, therefore there were a lot of adhesion the pneumo.The initial insufflation was performed by using a 11 mm trocar to achieve 15 mmhg at 25 lpm of flow.The sales rep was indicating that the insufflator's pressure reading was "random" and not steadily increasing like all other laparoscopy.During initial insufflation, assisting surgeon noticed that the pneumo was rock hard.At this time, the sales rep lowered the flow to 5 lpm and the surgeon inserted another trocar (assuming 5 mm) to remove adhesion surrounding the primary trocar (11 mm).The pneumo stabilized to 15 mmhg of pressure and surgery was completed without any further incident.".

• Brand Name: NEBULAE I
• Common Device Name: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 9578467
• Report Number: 0001450997-2020-00001
• Device Sequence Number: 3229499
• Product Code: HIF
• UDI-Device Identifier: 00817183020219
• UDI-Public: 00817183020219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: No Information
• Device Model Number: 7-650-00
• Device Catalogue Number: 7-650-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1