
Stryker · Model Neptune SafeAir
Safety and Satisfaction: Helps reduce exposure to smoke related biohazards Efficiency: Eliminates need for nurses with smoke tube, freeing up space at the table and hands to assist. Integrates with existing monopolar electrosurgical generators and smoke evacuation systems (22mm inlet) like that in the Neptune 3 Waste Management System. Performance: Helps maintain a clear operative site and its ergonomic design aids transition from standard electrosurgical pencils. Ergonomics: Designed to preserve surgeons natural technique via a lightweight and ergonomic electrosurgical pencil. ULPA filtration in accordance with AORN guidelines. Auto-activation via integrated sensor that detects pencil current. Lighted indicator visibly tracks filter life; shows when change is needed. Proprietary vacuum design enables near instant "on tip" suction at the power level set. Multiple activation codes; Automatic, continuous and footswitch. Adjustable time delay to enable maximum smoke evacuation.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: Plume not captured, weak airflow, blower ramps but flow is low.
Root cause: Loaded ULPA / charcoal filter, a worn blower / turbine, or a leak / kink in the hose.
Symptoms: Filter-change alarm, reduced airflow, odour breakthrough.
Root cause: ULPA / activated-charcoal filter at end of its capacity.
Symptoms: Evacuator does not start with the ESU, or runs continuously.
Root cause: The ESU-sensing cuff / cable or the auto-activation board.
Symptoms: Noisy, weak, or dead blower even with a new filter.
Root cause: Worn blower / turbine bearings or motor.
Symptoms: Very loud in use, speed will not adjust.
Root cause: Worn blower or a speed-control fault.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| ULPA / activated-charcoal filter | Consumable | $$ | Easy |
| Blower / turbine assembly | Periodic replacement | $$$ | Difficult |
| ESU-sensing cuff / auto-activation board | Major service part | $$ | Moderate |
| Hose / wand adapters | Frequent wear item | $ | Easy |
| Speed-control board | Major service part | $$ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Synced live from the FDA openFDA API.
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Due to a distribution error, product from the affected lot was shipped expired.
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.
The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking.
The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.
Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Warning Labels, which are pending distribution, are required on all Neptune devices. Further investigation found the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance and therefore are not legally marketed without determination of their safety and effectivene
Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
The grounding pin may break inside of the electrical plug, resulting in a shock hazard.
Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
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