Olympus Endoscope Recall Issued Due to Risk of Distal Ends Becoming “Abnormally Hot”

Olympus is recalling of a number of endoscopes due to a risk that the medical device may overheat, potentially causing patient or user injury. 

Am Olympus Endoeye HD II video telescope recall was announced through a field safety notice issued after the manufacturer received a complaint of a damaged temperature sensor at the tip of the Endoeye, which “caused the distal end to become abnormally hot.”

Olympus warns that excessive heating of the device could result in the injury of a patient or user. There have been no patient injuries or user injuries reported.

The recall impacts Olympus Endoeye HD II video telescopes with model numbers WA50040A and WA50042A.

According to Olympus, a repair for the problem will not be available until January 2016. However, the company is asking health care professionals and other customers to return the devices now, so they can disable the “Fog Free” feature on the endoscopes, which they say is causing excessive heating at the distal end.

The company says it will again contact customers once repairs are available so that they can be returned for a permanent fix.

Olympus Endoscope Problems

The recall comes amid continuing questions about the safety of a different type of endoscope sold by Olympus, known as a duodenoscope, which has been linked to reports of hospital infection outbreaks due to problems cleaning the device between patients, even when the instructions provided by Olympus were followed.

Earlier this year, outbreak of carbapenem-resistant enterobacteriaceae (CRE) at UCLA’s Ronald Reagan Medical Center was linked to Olympus duodenoscopes, causing at least seven infections and two deaths.

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, but there have been problems with the “reprocessing” instructions used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In August, the FDA posted a warning letter to Olympus, indicating that the company had failed to report links between the company’s devices and serious patient infections, injuries and deaths. Two other duodenoscope manufacturers, Pentax and Fujifilm, also received FDA warning letters.

Also in August, the FDA issued a safety communication expanding cleaning instructions for duodenoscopes used in ERCP procedures. Olympus Corp. issued expanded cleaning instructions which were approved by the FDA earlier this year.

In October, the FDA ordered new mandatory studies designed to help the agency analyze the effectiveness of the current cleaning instructions with endoscopes made by Olympus and other manufacturers, examining how reprocessing is implemented in real-world hospital settings. The agency indicates that the collected data will help it make decisions that will reduce the risk of duodenoscope infections and outbreaks.

Several duodenoscope infection lawsuits have already been filed  against Olympus over the infections linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.