(b)(4).Based on discussion with fda on (b)(6) 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: no known impact or consequence to patient.Loss of or failure to bond.Actual device evaluated.Wear problem.Device repaired and returned.(exemption number e2015036).
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A customer device was returned to pentax medical on (b)(6) 2018 for routine service due to 522 pms study.Inspection of the unit was performed on (b)(6) 2018 where the quality control inspector found the following: distal cap - fixed type failed epoxy seal integrity inspection.Air/ water socket cylinder o-ring chipped.Passed wet leak test.Umbilical cable dent.Passed dry leak test.Customer complaint confirmed.Operation channel- primary mild resistance.The scope's repairs included the distal case/cap, which was replaced and/or resealed pursuant to the field correction, and returned to the user on (b)(6) 2018.
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