MAUDE Adverse Event Report: DEPUY MITEK LLC US IMGMGMNT_PHOTOVIDEO SYSTEM; IMAGE MANAGEMENT

Catalog Number 242325

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

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.

Manufacturer Narrative

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).

Manufacturer Narrative

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.

• Brand Name: IMGMGMNT_PHOTOVIDEO SYSTEM
• Type of Device: IMAGE MANAGEMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10520934
• MDR Text Key: 207938013
• Report Number: 1221934-2020-02533
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1