Our health care system began use of the stryker surgicount system in (b)(6) 2020.From (b)(6) 2020 until present across the health care system issues related to the sponges supplied for use with the surgicount system have had repeated defects reported that could have impact on patient safety.A total of 12 recorded incidents have been reported while in patient use.The following is a breakdown of the defects: 6 are for missing master qr code band, 2 are related to blue loop detachment, and 4 are related to shredding or fraying of the sponge.Stryker has been notified and an independent test of unused products was conducted at our facility per their recommendation with 11 results of the product proving defective during the testing.The defective sponges are present in both the custom sponge packs as well single sponge packs.The sponges are from varied lot number and product id numbers.Fda safety report id# (b)(4).
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