Pentax medical was made aware of a complaint on (b)(6) 2017 stating the following "we have sent in our fna scopes multiple times for "md not being able to see needle".It is usually only with certain mds.We had this case yesterday where we used all 3 fna scopes and none of them was the md able to see the needle on all passes.When the scope is out we can see how the needle moves to the side vs staying in the middle.Can push back in place when out of the patient of course.I am not sure if you have had this issue before and can help out mds on how to control the scope to enable them to see the needle.In this case, dr.Li did come and we were able to see the needle after manipulating the scope." involving pentax video gastroscope ultrasound-linear array eg-3870utk/serial (b)(4) no serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported by the user.On 17-jul-2017, pentax medical followed up with the territory manager to inquire on when the units will be returned for further evaluation, no additional information was received.
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