Tiny cracks and gaps in the adhesive seals used on Pentax Ed-3490K duodenoscopes, a specialized endoscope used to diagnose and treat certain gastrointestinal conditions, can trap bacteria and make thorough cleaning and high-level disinfecting difficult, which can increase the risk of infection transmission between patients, the Food and Drug Administration (FDA) warned in a Safety Communication. The issue is related to an issue with the design and manufacturing of the ED-3490K duodenoscope. Cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, “which can lead to microbial and fluid ingress,” according to the ... Read More
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