It was reported by the affiliate in (b)(6) that before a knee arthroscopy surgery on an unknown date, it was observed that the evo 4k image management system on the purevue arthroscopy tower displayed "no video input" with color bars upon start-up.The staff pointed this unusual display to the doctor, but there was no time to fix the problem and the surgery started.The surgeon was taking images, but none of them were stored on the evo 4k (software version 1.7.24).There were no delay in surgery and adverse patient consequences reported.No additional information was provided.
|
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: d4: the serial number was reported as unknown on the initial report and has been updated as (b)(4).
|
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 before surgery started the evo 4k image management system on the purevue arthroscopy tower displayed "no video input" with color bars.This was not the case for the prior two cases on the same day.The staff pointed this unusual display to the doctor, but there was no time to fix the problem and the surgery started.The surgeon was taking images, but none of them were stored on the evo 4k (software version 1.7.24).The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, the display showed ¿no video input¿ and the color bars.Also, it was observed in the photos that it was happened during live -video (test, test).Therefore, complaint reported was confirmed.Hands on test should provide the evidence necessary to determine a specific root cause.The possible root cause for the reported failure can be attributed to a lack of maintenance which may cause a connection failure to display the video.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.
|