Hoya (TYO:7741) subsidiary Pentax Medical has issued an urgent field safety notice for some of its video duodenoscopes and single-use distal end caps.
The notice out of Germany warns on complaints of risk of improper attachment of its single-use sterile distal end cap with elevator OE-A63 on its Pentax Medical Video Duodenoscope ED34-i10T2. The issue could cause the cap to fall off, the elevator to not lift or the elevator to not return to its neutral position.
Pentax Medical said it has revised its instructions for use to describe more clearly how to attach the distal end cap securely to the endoscope. The company suggests that devices can continue to be used safely by attaching the end cap properly.