Additional information provided in g.1., g.2.H.3., h.6., and h.10.The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.The wet returned sample was visually inspected and a piece of surgical tape was wrapped around the admin tubing.The administration tubing was bent at 6" near the cassette insertion.The sample was then tested on a calibrated console and could prime and tune with the ultrasonic handpiece successfully.Irrigation flow performance was measured with the bent tubing and the sample met specifications.The cassette fluidics calibrated and functioned per specifications during laboratory evaluation.The root cause of the customer's complaint is related to an error that can occur during the insertion of the product into the procedure pack prior to sealing.The tubing was possibly bent acutely when positioned into the container tray (prior to sealing).Action will not be taken for this occurrence.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.The manufacturer internal reference number is: (b)(4).
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