Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Endo Peanut 5 mm Device. [Item code: 173019; Lot numbers: M5K04X to M7A01X; Expiration: October 2020 through January 2022].
According to the manufacturer, the voluntary recall is being conducted following reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process.
The use of products with this issue may increase the potential for the tip to disengage resulting in possible extension of operating room time or the need for unintended radiation exposure via x-ray for detection of the foreign body. While four reports indicate that patients required an intraoperative x-ray to locate the disengaged tip, and in one case the tip was not retrieved subsequent to x-ray, no patient injury or impairment has been reported.
The manufacturer requests customers to quarantine and return any unused products..
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 May 2017