Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the sheath was not fitting.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: intermittent / no video.Cord damaged.Minor scratches on the device.The device was however deemed non-repairable and was 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 sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the cord on the camera head ac - c-mount device was loose.During in-house engineering evaluation, it was observed that the device was working intermittently with no video.There were no adverse patient consequences reported.No additional information was provided.
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