This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that the images cannot be displayed in the live video menu as the attached photo shows during the demo.The complaint device was received at the service center and evaluated.Also, mitek conducted visual inspection of photo provided by customer.During evaluation, it was observed that the live video did not have any channels and image was black; after further inspection it was found that the video capture card was not being detected.Upon visual inspection of the photo, the display showed a black image.The testing of the unit was completed per the service manual, the unit passed all functional tests and is fully operational.Per service manual operational and diagnostic, the reported failure was confirmed.The possible root cause could be that the video card have been damaged from a source with electrical intensity not equal to what it can handle.A manufacturing record evaluation was performed for the finished device [0319040c] number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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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