MAUDE Adverse Event Report: DEPUY MITEK LLC US RAD32" 4K/UHD MEDICAL DISPLAY; EDNOSCOPIC VIDEO IMAGE SYSTEM

Catalog Number	242672
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported by the sales rep via email that during a shoulder scope procedure the radiance 32¿ 4k/uhd medical display and all in one ccu + light source, it was noticed green specks.Also, the customer reported to the sales rep that there is flashing of color bars and shaking screens.The procedure was completed the procedure by using another tower with no patient harm but there was a ten minute surgical delay to the case.The sales rep stated that he spent two hours re-wiring, re-booting, and troubleshooting without any success.The devices will be returning for evaluation.
Additional 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 - the complaint device was received at the service center and evaluated.The sales rep reported green specks, flashing of color bars and shaking screens.During evaluation, intermittent green specs/interference on certain colors were observed, therefore this complaint can be confirmed.It was found that the primary video board was damaged.Pca, cerberus main video controller was replaced to resolve the issue.After repair, the device was found to be working according to the specifications.The damaged primary video board is identified as the root cause of the reported problem.A manufacturing record evaluation was performed for the finished device serial number (b)(6) 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.

• Brand Name: RAD32" 4K/UHD MEDICAL DISPLAY
• Common Device Name: EDNOSCOPIC VIDEO IMAGE SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9639211
• Report Number: 1221934-2020-00344
• Device Sequence Number: 19530865
• Product Code: FCW
• UDI-Device Identifier: 00851455007812
• UDI-Public: 00851455007812
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1