[UPDATE 03/27/2013] The FDA is aware of health care facilities' concerns about implementing Stryker's Neptune Pre-use Checklist and training program to comply with Stryker's updated Certificate of Medical Necessity (CMN) program. Stryker has a website to address customer concerns that provides training materials, including webinars and a training assessment, for facilities using the Neptune 1 Silver and Neptune 2 Ultra devices under the CMN.
Facilities should contact Stryker directly if they need an extension of the March 25, 2013 deadline.
[UPDATE 03/15/2013] In the past 6 months, the FDA has become aware of additional death and injury reports related to these recalled devices. The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied and were associated with users of the device who had not been properly trained on how to use the device.
Stryker and the FDA are particularly concerned about these cases, since a requirement for continuing to use these devices under the Certificate of Medical Neccesity is to ensure that all users are adequately trained and have implemented the use of the Pre-use Checklist.
Stryker issued updated recall notifications dated Feb. 20, 2013 for the Neptune 1 Silver and the Neptune 2 Ultra reminding customers of the steps they need to take to continue using these devices. Health care facilities that must use these devices need to ensure the following steps are completed, as stated in their Certificate of Medical Necessity:
- Ensure ALL USERS of the Neptune 1 Silver and Neptune 2 Ultra are properly trained before the use of the device and aware of the risks associated with the device.
- Implement the Neptune Pre-use Checklist within your facility. This checklist must be completed BEFORE EVERY PROCEDURE for which a Neptune 1 Silver and/or Neptune 2 Ultra device is used.
- Identify a training facilitator or device champion for each facility/hospital who will ensure the Neptune Pre-use Checklist is implemented consistently with your facility’s standard protocol, and in a way that makes sense for your facility to document the checklist was completed.
- Prior to using the device, health care providers should follow the recommendations listed in the updated safety communication to mitigate the risks of using these devices.
[UPDATE 10/26/2012] FDA notified healthcare professionals of a Class I recall of the Stryker Neptune Rover Waste Management Systems. See recall notice for list of all affected models.
AUDIENCE: Risk Manager, Surgery
ISSUE: The FDA and Stryker received one report of serious injury and one report of death as a result of tissue damage resulting from use of the Neptune 2 Ultra Waste Management System. The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and that the instructions for use on the device did not specifically warn against this action. When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.
BACKGROUND: The Neptune 1 Silver Waste Management System (Neptune Silver) and the Neptune 2 Ultra Waste Management System (Neptune 2 Ultra) are intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities. The Neptune 2 Ultra can also remove smoke generated at surgical sites by electrocautery or laser devices. Both systems consist of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied through the device’s docking station.
RECOMMENDATION: Healthcare providers should NOT to use the Neptune 1 Silver Waste Management System or the Neptune 2 Ultra Waste Management System unless there is no alternative suction device or waste management system available. Facilities should evaluate the risks and benefits of using the Neptune 1 Silver or the Neptune 2 Ultra. If your facility does not have an alternative means for surgical waste disposal during surgery, you must complete the Certificate of Medical Necessity and send it back to Stryker. The facility must file a Certificate of Medical Necessity with Stryker by Oct. 12, 2012 in order to continue to receive supplies and customer support for this device. See the FDA Safety Communication for additional information and recommendations.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/27/2013 - Updated FDA Safety Communication - FDA]
[03/15/2013 - FDA Safety Communication - FDA]
[03/15/2013 - Urgent Medical Device Recall Notification (Revised) - Stryker]
[03/15/2013 - Neptune Pre-use Checklist - Stryker]