The following information updates our March 14, 2013 communication.
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 to implement the updated CMN.
For information about legally marked alternative devices, please visit the FDA medical devices database and search for “JCX” and “BTA” in the product code field.
The FDA's role in this recall is to monitor and assess the adequacy of Stryker's voluntary recall of the Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems.
Because the FDA is concerned that hospital staff may not have been adequately trained to use these devices properly, it is critical for health care facilities to implement the updated CMN program as soon as possible. Stryker's checklist and training program has been established in response to additional death and injuries related to these devices, after the initial CMN was implemented. When used incorrectly, the high-flow, high-suction vacuum can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death. For example, in one report, a patient died after the Neptune was connected to the chest tube during a pneumonectomy and the suction pulled the heart muscle from its left position in the chest, causing a tear in the aorta.
If you have additional questions about how to implement Stryker's checklist, the training program, requesting an extension, or any other concerns regarding this recall, please contact Stryker at 269-389-2316 or firstname.lastname@example.org for more information.
Original Date Issued: Oct. 05, 2012
Date Updated: March 14, 2013
Date Updated: March 26, 2013
- Surgeons, anesthesiologists, operating room nurses/technologists and surgical technicians
- Hospital and/or facility administrators, surgical directors, ambulatory surgery centers, risk managers, chief nurse executives, purchasing departments
- Neptune 1 Silver Waste Management System (Neptune 1 Silver)
- Neptune 2 Ultra Waste Management System Device (Neptune 2 Ultra)
The Neptune 1 Silver Waste Management System (Neptune 1 Silver) and the Neptune 2 Ultra Waste Management System (Neptune 2 Ultra), manufactured by Stryker Instruments, 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.
Stryker manufactured the Neptune 2 Ultra from February 2001 through April 2012 and distributed it from March 2001 through August 2012. Production of the Neptune 2 Ultra is currently on hold. Stryker no longer manufacturers the Neptune 1 Silver; however, they will still maintain and support the device to customers granted a Certificate of Medical Necessity by the firm until March 1, 2014.
- To alert health care providers to immediately begin transitioning from using the Neptune 1 Silver and the Neptune 2 Ultra Waste Management Systems. The FDA recommends that alternative legally marketed devices be used in their place.
- To alert health care providers that IF no alternative suction device or waste management system is available, they MUST take additional steps to continue the use of these devices under the Certificate of Medical Necessity.
- To alert health care providers that Stryker will not seek FDA 510(K) clearance for the Neptune 1 Silver and Stryker will withdraw all support for the use of this device by March 1, 2014. The Certificate of Medical Necessity program will end for the Neptune 1 Silver on March 1, 2014—after that date, the Neptune 1 Silver should not be used.
Summary of Problem and Scope:
In the months following Stryker's September 2012 recall notification and FDA's October 2012 Safety Communication, the FDA has become aware of additional death and injury reports related to these devices, in facilities that had previously obtained a Certificate of Medical Necessity (CMN) to continue using them.
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 CMN is to ensure that all users are adequately trained. When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra Waste Management Systems can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.
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. The FDA also wants to emphasize the importance of following these recommendations, listed below:
Recommendations for Health Care Providers:
- The Neptune 1 Silver and Neptune 2 Ultra devices should not be used unless there is no acceptable alternative suction device or waste management system available. The FDA and Stryker recommend that:
- Users of the Neptune 1 Silver should transition to a legally marketed device as soon as possible. Stryker has informed the FDA and its customers that it does not intend to submit a 510(K) premarket notification for the Neptune 1 Silver and it will be withdrawn from the market. All support for this device will stop March 1, 2014.
- Users of the Neptune 2 Ultra should transition to a legally marketed device as soon as possible. Stryker is currently working with the FDA on the 510(k) premarket notification for the Neptune 2 Ultra.
- If your facility does not have an alternative means for surgical waste disposal during surgery, the FDA advises you to evaluate the risks and benefits before you use these devices. Facilities continuing to use the Neptune 1 Silver and Neptune 2 Ultra must update their Certificate of Medical Necessity (CMN) with signatures from their CEO or CEO designee and return it to Stryker by March 25, 2013.
- 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 below to mitigate the risks of using these devices:
- Alwaysconsider the type of tissue associated with the surgical procedure before using this system and adjust suction levels accordingly. Use of inappropriately high level of suction may result in severe injury or death.
- Ensure that each vacuum is attached to the correct port, because all vacuum ports appear identical, making it more difficult to know which port corresponds with the appropriate level of suction.
- Verify that you are using the intended units of measure when setting suction levels to avoid operating the devices at a higher or lower level of suction than you expect and/or need for a specific clinical application. This device uses multiple units of measurement that may be confused, leading to errors in suction levels: inches of mercury (in- Hg); millimeters of mercury (mm-Hg), kilopascals (kPa)
- For example the digital readout may read 21 in-Hg which would be approximately 530 mm-Hg.
- Ensure you understand the adjustable vacuum limits and maximum limit for each device:
- The Neptune 1 Silver vacuum limit is adjustable from 254 – 483 mm-Hg or 11.0 – 19.0 in-Hg and has a maximum vacuum level of 483 mm-Hg or 19.0 in-Hg
- The Neptune 2 Ultra vacuum limit is adjustable from 50 – 530 mm-Hg, 2.0 – 21.0 in-Hg, or 7.0 – 71.0 kPa. and has a maximum vacuum level of 530 mm-Hg, 21.0 in-Hg, or 71.0 kPa.
- Do NOT apply high flow suction or allow extended exposure of suction to tissue associated with procedures that require no suction, low vacuum or low flow suction.
- Do NOT use the Neptune 1 Silver in low suction applications that require vacuum levels below 254 mm-Hg or 10.0 in-Hg as this could result in injury to vital anatomical structures, and/or hemorrhage, both of which may result in serious injury and/or death.
- Do NOT use the Neptune 2 Ultra in low suction applications that require vacuum levels below 50 mm-Hg, 2.0 in-Hg, or 7.0 kPa as this could result in injury to vital anatomical structures and/or hemorrhage, both of which may result in serious injury and/or death.
- Do NOT use these devices for respiratory tract suction.
- Do NOT use these devices to provide suction to other suction powered accessories such, as Pleur-evac devices.
- If you plan to continue using the Neptune 1 Silver and/or the Neptune 2 Ultra devices, you must update your Certificate of Medical Necessity and send it back to Stryker Instruments at email@example.com or fax 866-521-2762 by March 25, 2013. If a Certificate of Medical Necessity is not received by this date, Stryker will not be able to provide any disposable accessories, replacement parts or provide service for your device(s).
- Customers with questions about theses devices and the CMN program, including implementing the Neptune Pre-use Checklist, should contact Stryker Instruments at 269-389-2316 or firstname.lastname@example.org for more information.
- On March, 25, 2013, the FDA issued an updated Safety Communication to address concerns from facilities about Stryker's Certificate of Medical Necessity (CMN) program, the implementation of Stryker's Neptune Pre-use Checklist and training program, and to inform customers about how to request an extension from Stryker of the March 25, 2013 deadline.
- On March 14, 2013, the FDA issued an updated Safety Communication about the Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems. Only customers that update the Certificate of Medical Necessity can use the Neptune 1 Silver and Neptune 2 Ultra devices.
- On Oct. 05, 2012, The FDA issued a Safety Communication about the Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems.
- On Aug. 15, 2012, the FDA classified Stryker's recall of the Neptune 1 Bronze, Neptune 1 Silver, Neptune 1 Gold, Neptune Gold International and Neptune 2 Ultra Waste Management Systems as Class I, the most serious type of recall. This recall included the following revised Instruction for Use Warning: Do Not apply High Flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction. All Neptune 1 Bronze, Neptune 1 Gold and Neptune 1 Gold International customers should have received warning labels to apply to the device in an updated notice mailed to customers on Sept. 25, 2012.
- The FDA will continue to monitor this issue and keep the public informed if new information becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Neptune 1 Silver and/or Neptune 2 Waste Management Systems, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
To help us learn as much as possible about the adverse events associated with these devices, please include the following information in your reports, if available:
- Product Name
- Lot Number
- Relevant events prior and subsequent to the referenced problem
- Concomitant medical products
- Details of the adverse event and medical intervention (if required)
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at Industry.Devices@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
This document reflects the FDA's current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.