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.
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