If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 1 similar complaint for this lot of cases that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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It was reported that pressure sensor was bad.It was reported that 5 irrigation tubing devices were used during the same procedure and each one would not stop filing the chamber.Replaced tubing and finished case.There was 15 minutes delay in the procedure.Please see also medwatch reports: 1221934-2018-53489, 1221934-2018-53490, 1221934-2018-53492, 1221934-2018-53493.
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