Additional information provided in d.9, h.3., h.6., and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria the returned sample was visually inspected.Visual inspection confirmed the tubing were detached from the probe engine.Based on the indentation mark, the aspiration line was once fully inserted into the probe engine.Insufficient solvent caused the gray and black tubing to depart from the probe engine during pressurizing on the console.The root cause of the customer¿s complaint is related to an error during the manufacturing assembly process of the probe.Action will not be taken for this occurrence.After an investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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