FDA warns against use of Stryker surgical suction systems

Oct 5 (Reuters) - U.S. health regulators warned on Fridayagainst the use of systems made by Stryker Corp forremoving surgical waste from patients after receiving reports ofone death and one serious injury due to tissue damage.

The Stryker systems, called Neptune 1 Silver and Neptune 2Ultra Waste, use powerful suction to collect and remove surgicalfluid waste in operating rooms and smoke at surgical sitescaused by electrocautery or laser devices.

When incorrectly applied, as was the case with the death andserious injury, it can cause hemorrhaging and soft tissue,muscle, and vital organ damage, the U.S. Food and DrugAdministration said in a warning on its website.

Healthcare providers should not use the Neptune 1 SilverWaste Management System or the Neptune 2 Ultra Waste ManagementSystem unless there is no alternative suction device or wastemanagement system available, the agency cautioned.

(Reporting by Bill Berkrot; Editing by Tim Dobbyn)

((bill.berkrot@thomsonreuters.com)(1 646 223 6030))

Keywords: STRYKER FDA/

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