MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. NEBULAE® SRS LAPAROSCOPIC SURGICAL SMOKE REMOVAL PUMP; SURGICAL PLUME EVACUATION SYSTEM

Model Number	7-700-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
There is no product malfunction reported or suspected in the procedure that preceded this event.The device history record for 200071mdge from april of 2022 (mo 15801) was reviewed and there was nothing noted in the device history record that could have caused or contributed to the post-op death.As indicated in the complaint description by the initial complainant, the procedure was completed successfully with no know malfunction or complication during the procedure execution.The cause of death is unknown by the manufacturer, however laparoscopic surgeries (hysterectomies) do have risks associated with them.The nor-doc-dra-0034 risk analysis was reviewed.Risk id 7.8.1.10 (pressure) and 7.8.2.1 (infection) are the two line items that could result in a risk of death.It was not stated that the patient abdomen experienced any increased pressure events during the surgery, and it is unknown if the patient experienced any infections post procedure.The risks are mitigated through design and testing to insure the tubing is adequately designed to prevent the introduction of room air and the manual contains clear instruction and warning regarding the use of accessories and inspection of the tubing sets prior to use for damage.The risks associated with the use of the device leading to death is considered less than remote.If further information was to become available or product returned from the field for further investigation, a follow up report will be submitted at that time.This issue will continue to be monitored through the complaint and post market surveillance systems to assure patient safety.
Event or Problem Description
On 04/10/2024 nti was informed that there was a patient death after a case that involved the use of nebulae srs.There was no nebulae srs complaint to report from this surgery.The subject died post-op following a robotic hysterectomy.City of hope is conducting an autopsy to determine the cause of death.

• Brand Name: NEBULAE® SRS LAPAROSCOPIC SURGICAL SMOKE REMOVAL PUMP
• Common Device Name: SURGICAL PLUME EVACUATION SYSTEM
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL 60123
• MDR Report Key: 19287395
• Report Number: 0001450997-2024-00005
• Device Sequence Number: 7070177
• Product Code: GCX
• UDI-Device Identifier: 00817183020684
• UDI-Public: 00817183020684
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NTI K202944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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?: No
• Device Model Number: 7-700-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown