(b)(4).Based on discussion with fda on may 8, 2017, all inspectional failures are being reported as mdrs notwithstanding the fact that the presence of discontinuities, gaps or bubbles does not necessarily have either technical or clinical significance.Event problem and evaluation codes: (b)(4).(exemption number e2015036).
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Pentax of america initiated field correction 2017-001-c which included inspection of the seal around the distal body and distal cap of the ed-3490tk duodenoscope pursuant to predefined inspection criteria (et-hf-p-0013 rev.00).The objective of the inspection was to verify there were no defects/discontinuities in the seal between the distal body and distal cap.The inspectional criteria was defined as, "all seal surfaces observed shall be continuous and smooth with no outward signs of discontinuity, gaps or bubbles." a device was considered to fail the inspection if any element of the criteria was not met.The device was inspected by a representative from pentax (b)(4) on 04/13/2017 for the seal between the distal body and distal cap, the device failed the inspection criteria.
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