Pentax medical was made aware of an event that occurred at a facility in the united states.On 09-sep-2019, pentax received a service notification repair request for "brush stuck/broken in channel".During inspection the following was found: "accessory stuck in primary operation channel", involving the pentax medical video gastroscope ultrasound, model eg-3670urk, serial number (b)(4).Pentax medical customer service team performed good faith efforts to inquire circumstance of when the event occurred.The user stated this occurred during reprocessing and the endoscope was subsequently removed from circulation and called in for service.On 07oct2019, repairs were completed where the stuck accessory was removed, and repairs were performed and returned to the user.On 06-nov-2020, a device history record(dhr) review for model eg-2990i, serial number (b)(4) was performed under ivai-20-110017, the dhr review confirmed the endoscope was manufactured on 29-nov-2013 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.Instructions for use(ifu), includes the following warning section 2-1-3, 3) "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.
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