According to FDA reports the device in question is the Pentax ED-3490TK, a video-supported duodenoscope suspected of becoming compromised due to cracks or gaps in the adhesive seals, increasing the likelihood that fluids, microbes or anything else that could potentially foster infection could break through and pose a health risk. The FDA went on to say that the video tube is a challenge to clean and disinfect properly.
Thus, the increased concern for risk of infection.
Seals can, and have proven to be an Achilles’ heel for many devices and incidents. On the space Shuttle Challenger, for example, the tragic 1986 explosion was traced to a failed O-ring, or seal, on one of the solid rocket boosters. The seal had been compromised by the cold prior to launch, and the failed seal allowed heat and hot gasses to reach the fuel tank.
In the case of the Pentax product, an ill-fitting adhesive seal can allow bodily fluids potentially carrying infection to come into contact with an area of the duodenoscope that is tricky to clean.
As endoscopes and duodenoscopes are re-used between patients, any infection from a previous patient not effectively eradicated from the device has the potential to be passed along to the subsequent patient, along with the risk of infection. Many an endoscope lawsuit has emerged from endoscopes and duodenoscopes suspected of having design flaws. In 2015 Pentax was one of a handful of medical device manufacturers accused of playing a role in a deadly string of outbreaks involving so-called ‘superbugs’ that hit a collection of hospitals.
Pentax, in response to the FDA directive released in January, released a statement that said “Pentax is working closely with the FDA to further evaluate and mitigate the potential risk of infection associated with leakage, if leakage were to occur, into or out of the distal cap area.”
The focus of the FDA communique in January remained primarily with the cleaning aspect of endoscope and duodenoscope use, including a caution that technicians and hospital staff should refrain from attempting to clean and disinfect duodenoscopes by hand, giving preference to the use of an automated cleaning machine.
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A damning US Senate report released in January, 2016 noted that Pentax was amongst manufacturers found to have failed to meet regulatory requirements. Pentax was taken to task for failing to prove that its cleaning instructions were effective on a consistent basis.
However, the FDA itself did not escape the wrath carried in the US Senate report. The report authors concluded the FDA knew in September, 2013 that there were concerns with duodenoscopes, but did not alert the public until 17 months later.
A fact not lost on any plaintiff bringing an endoscope negligence lawsuit