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	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.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 complaint submission tool that at the start of an arthroscopy the (b)(6) didn¿t showed proper imaging, the image was flickering and had horizontal lines across the monitor.After several power cycles with the cable and setting alterations on the system, it starting working properly.No patient consequence and no surgical delay was reported.No additional information was provided.Additional information from the affiliate confirmed a surgical delay did not occur.
Additional Manufacturer Narrative
H10 additional narrative: investigation summary = > according to the information provided, it was reported that at the start of an arthroscopy the rad32" 4k/uhd medical display didn¿t showed proper imaging, the image was flickering and had horizontal lines across the monitor.After several power cycles with the cable and setting alterations on the system, it starting working properly.As the source of the issue is not clear the display will not be sent for repair.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.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.Device history lot = > a manufacturing record evaluation was performed for the finished device serial number:(b)(4) and no non-conformances were identified.

• 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: 9857057
• Report Number: 1221934-2020-00923
• Device Sequence Number: 19621352
• Product Code: FCW
• UDI-Device Identifier: 00851455007812
• UDI-Public: 00851455007812
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/10/2020
• Patient Sequence Number: 1