Olympus (TYO:7733) said today it is initiating a select recall of its EndoEye HD II endoscopes over issues with damaged temperature sensors causing the distal ends of the device to become ‘abnormally hot’.
The devices are used during endoscopy and endoscopic surgeries along with other tools within the thoracic and abdominal cavities, including the female reproductive organs, the company said.
Olympus said it has not received any reports of injuries from the malfunction, but that the malfunction could result in patient or user injury if not corrected.
The select recall affects model numbers WA50040A and WA50042A Olympus EndoEye HD II Video Telescopes, though Olympus did not release information on how many of the devices are affected.
The repair to correct the devices will not be available until January 2016. Olympus is still requesting the devices be returned to disable a ‘Fog Free’ feature to prevent excessive heating, and said it will retrieve the devices again once a fix is available in January.
The company requested any operators with the device contact them to find instructions for the return and repair of the scopes.
In October, Olympus was named by the FDA as it ordered it and 2 other Japanese duodenoscope makers to run post-market surveillance studies to evaluate how the devices are reprocessed in real-world conditions, after a deadly rash of so-called “superbug” outbreaks this year were linked to the devices.
The string of deadly infections were attributed to duodenoscopes made by Olympus, Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax subsidiary. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually. Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March, some of which led to patients’ deaths.
