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

Model Number 7-650-00

Device Problem Increase in Pressure (1491)

Patient Problem Skin Disorders (4543)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The insufflator, nti part number 7-650-00; serial number (b)(4) arrived at nti on 2/24/2021 from (b)(4) distributor (b)(4) inc.The device and complaint were evaluated under nti capa 21007.The device and complaint description were further evaluated by engineering and determined to be functioning normally.Per capa (b)(4): unit was received and inspected on 2/25/2021.The unit appear to be in good condition.The unit was then tested at different flow rates and pressure settings with both tap tubing and without tap tubing using an abdomen simulator.The unit performed as expected.No overpressure condition was observed.When overpressure was introduced by compressing the simulator bag the unit put out an alert (pressure reading on the device was max out at 50 mmhg) and vented as expected.The device history record for 90645hzf from (b)(6) 2015 ((b)(6)) was reviewed and the device passed all testing.Nothing out of the ordinary was noted.There have been five (5) complaints reported to nti for this device.The device complaint (b)(4) reported intermittent stopping of the unit.The unit was repaired by (b)(4)for a damaged card reader.The complaint was further investigated via nc 16030.Complaint (b)(4) (03/2017) reported a fault code 11.The unit was repaired by (b)(4).Complaint (b)(4) (05/2018) reported stopped flow suddenly 20-30 times in one surgery.Device was repaired/upgraded to rev f by (b)(4).Complaint (b)(4) (07/2019) device displayed "restriction" with over pressure situation.Device performed as expected during testing.Device was repaired replacing the prop conn reader with card guide assy and cable ties (which would not impact the complaint situation), unit was recalibrated and fqc tested for proper operation and the unit performed as expected.This alleged malfunction was reported to the fda via 0001450997-2019-00008 on 08/23/2019.Complaint (b)(4) (07/2020) reported fc 13 (flow fault), the complaint was not verified in service evaluation, but fc 13 was noted in device memory.The unit was flowing lower than specification; the repairs were done by replacing the proportional valve to address the fault code.The unit was recalibrated and passed all fqc inspections and testing for the unit.The investigation will proceed, any additional findings will be updated via a follow-up report.

Event Description

On (b)(6) 2021 northgate technologies was made aware of the following alleged event with an insufflator from distributor (b)(4) located in (b)(4), ".This unit could not maintain a stable pneumo and a patient's stomach was too bloated." further information was received after requests from northgate technologies in which the following information was provided: 02/20/2021 "was there any adverse effect to the patient? how was the procedure completed? - pneumohypoderma.Any other affects were not confirmed.The procedure was completed with another nebulae unit." and 2/22/2021 "this unit could not maintain a stable pneumo.There was no adverse event." therefore this complaint / event is being submitted as a device malfunction report as there was no adverse event.

• Brand Name: NEBULAE I
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 11532332
• MDR Text Key: 280456127
• Report Number: 0001450997-2021-00001
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00817183020189
• UDI-Public: 00817183020189
• Combination Product (y/n): N
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 02/24/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other