Stryker—CORE and RenB Universal Drivers: Unintended Activation May Occur
July 10, 2013 | Risk Management News
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In a June 28, 2013, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Stryker states that safety margin values were entered incorrectly into the programming software of the drivers below, potentially leading to the unintended activation of the drivers. Unintended forward or reverse activation of the drivers may result in patient bone or soft tissue injury. Stryker also states that the drivers may not reach 100% speed at full trigger depression in both forward and reverse, that the drivers may exceed full speed in reverse, or that the drivers may have excessive dead trigger travel before motor rotation in reverse. The manufacturer has not confirmed the...