Here’s what you should know.
1. Pentax identified several cracks and gaps in the adhesive seals between the distal cap and the distal tip in the Pentax ED-3490K duodenoscope.
Those gaps can lead to microbial and fluid ingress, and have proved challenging to both cleaning and disinfecting the device.
2. In February 2016, Pentax created and issued manual reprocessing instructions for the ED-3490TK to replace original device labeling instructions. The FDA recommends providers use the updated instructions for the ED-3490K.
3. The FDA recommends facilities discontinue use of any scopes showing visible signs of damage.
More articles on gastroenterology/endoscopy:
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