Medical device manufacturer, Ethicon, has issued a medical device safety alert concerning its HARMONIC HD 1000i Shears [Product Codes: HARHD20, HARHD36 ; Product Lots: U95A80, U95T0X, U95U1R, U95Y7G, U95F2T, U95524, U95F8W, U95E72, U95F07, U95U6A, U95L0A, U94Y9W, U9543R, U95R4F, U95C2A, U95T2Z, U95F6N].
The manufacturer has identified a rare condition in a small number of devices in which an internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device. Should the user not recognise continuous activation, inadvertent thermal damage to unintended tissue may occur during surgery.
The manufacturer advised users to identify, quarantine and return the affected product.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Jul 2021