Burns prompt recalls of airway scopes, electrosurgical pads

Editor's Note

Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes.

According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports of patient burns after surgical procedures employing Mega Soft pads, the company is limiting use of its Mega Soft Universal and Universal Plus reusable patient return electrodes (pads used to protect patients during electrosurgery) to patients aged 12 years or older. As reflected in updated product labeling and Instructions for Use (IFU), the restriction for children under the age of 12 is inclusive of product codes 0845, 0846, 0847, and 0848.

Megadyne has not identified any design or manufacturing defects nor determined a definitive root cause for the reports. Questions recall can be directed to local sales representatives or parent company Ethicon’s Resource Department at 1-877-ETHICON (1-877-384-4266).

The latter recall of Olympus bronchofiberscopes and bronchovideoscopes (devices used with cameras and lights to examine patients’ airways) also does not call for the removal of the products, according to a December 19 Food and Drug Administration (FDA) announcement. Rather, it is an “Urgent Medical Device Corrective Action” pertaining to how these products should be used to prevent injury. Olympus first notified customers on October 12, 2023, of potential adverse effects and reminded them to closely observe manufacturer’s warnings. 

According to the FDA announcement, there have been 192 complaints and four injuries related to problems occurring during high-frequency cauterization performed while supplying oxygen, or when the electrode section of an electrosurgical accessory was too close to the end of the endoscope. US customers with questions about this recall should contact Olympus at 1-800-848-9024 (option 1). Additional details and information, including a list of all relevant devices, can be found at the FDA website.