The device return is anticipated; however, at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.Upon review of the device history for serial number (b)(4), it was determined that the device was manufactured on 27 jun 2017 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).
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The customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the image cut in and out when the flexible tip was moved.A delay in the procedure of five (5) minutes occurred while another avl system was obtained.No harm to the patient or user was reported.
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