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The wet combined pak was visually inspected.The folded aspiration line at the entrance of the tubing insertion to the probe engine inside the rear shell was observed.The kink on the tubing happened during assembling the rear shell to the probe engine.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified, all corresponding production release specifications defined in the device master record were met.The most likely root cause for the customer¿s event is a manufacturing defect.The vitrectomy probe has a rear shell meant to improve the ergonomics of the handpiece, however, if the rear shell is improperly installed, it will result in the customers reported event.Based on the results of the investigation, no additional manufacturing or actions are required at this time.Current complaint tracking shows no adverse trends associated with this product or the reported failure mode.The observed kink in the aspiration tubing is mitigated through existing in-process controls whereby each probe undergoes a leak and flow test after final assembly to identify and prevent release of nonconforming units, including those with aspiration line kinks.Additionally, operators receive routine training on the probe assembly process to ensure proper technique and consistent assembly performance.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.No adverse trends have been observed associated with the reported product and event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).
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