Stryker Instruments Div. of Stryker Corporation: 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, 201

Agency Publication Date: August 15, 2012

Affected Products

Product: Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

Part 0700-003-000, all lot numbers IFU 0700-003-000

Lot Numbers:

numbers

Product: Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

120V Gold part numbers 0700-001-000 IFU 0700-001-700 230 V Gold 0700-002- 000, IFU 0700-002-707 Neptune 1 Gold Rover 0700-001-000 1/11/01 12/23/09 3/26/01 1/30/10 0700-001-700 Neptune 1 Gold Rover - International 0700-002-000 9/15/05 10/3/05 10/3/05 0700-002-707

Product: Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

Part : 0700-007-000, all lot numbers IFU Part number 0700-007-720

Lot Numbers:

numbers

Product: Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

Neptune 2 Rover Ultra (120 V) 0702-001-000 Neptune 2 Rover Ultra (230 V) 0702-002-000 associated IFU 0702-002-700

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61747

Status: Resolved

Manufacturer: Stryker Instruments Div. of Stryker Corporation

Manufactured In: United States

Units Affected: 4 products (2657; 5925 domestic 2 international; 1075; 10,394 domestic, 276 international)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

Part 0700-003-000, all lot numbers IFU 0700-003-000

Lot Numbers:

numbers

Part : 0700-007-000, all lot numbers IFU Part number 0700-007-720

Lot Numbers:

numbers

Product: Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

Neptune 2 Rover Ultra (120 V) 0702-001-000 Neptune 2 Rover Ultra (230 V) 0702-002-000 associated IFU 0702-002-700