Device product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-001
Z-0367-2025
Product summary
- Event
- Event 95502
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,620 eaches
- Official record key
device-enforcement:Z-0367-2025
Official wording
Reason: 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
Code information: GTIN: 07613327117219 Lot Number: 64117291
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Derived failure modes
-
Unknown
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