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 device was received and evaluated at the service center.The reported complaint that the console of the camera head ac c-mount does not recognize the camera when it¿s plugged in, was confirmed.It was found that the device displayed the video intermittently.However, the device was found to be irreparable and was placed into long-term hold.Given the information provided, we cannot discern a definitive root cause of the reported complaint by the customer.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4) ), and no non-conformances were identified.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.
|
It was reported by the sales rep that during a shoulder arthroscopy procedure on
(b)(6) 2020, it was observed that the console on the camera head ac - c-mount device did recognize the camera when it was plugged in; and that the color bars remained on the screen but no picture came up.During in-house engineering evaluation, it was determined that the device displayed the video intermittently.Another like device was used to complete the procedure with less than 10 minutes of delay.There were no adverse patient consequences reported.No additional information was provided.
|