If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device was not functioning and did not produce image on the monitor.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: intermittent / no video, minor scratches on the device.The device was however deemed non-repairable, and it is being placed into long term hold.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.At this point in time, no corrective action is required, and no further action is warranted.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.
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It was reported by the sales rep that during a laparoscopy procedure on (b)(6) 2021, it was observed that a camera head ac - c-mount device was not functioning and did not produce image on the monitor.During in-house engineering evaluation, it was determined that the device was working intermittently that there would not be video.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
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