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	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via email that the radiance 32¿ 4k/uhd medical display provided as replacement of (b)(4) is also providing the image with too much glare.No procedure or patient was involved.
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 supplier facility and evaluated.The sales rep reported an issue of the device was providing the image with too much glare.Per evaluation findings, this complaint can be confirmed.It was noticed during evaluation that the factory film was still covering the front glass.If the unit was being used with this film still on it, it could increase the glare when trying to view the screen.Additionally, it was found that the 4x3g-sdi signal format was set to 2 sample interleave.This was resulting in the image appearing too light and nearly whited out.The setting was changed to square division and the image displayed clean and sharp.The potential causes for these issues are not related 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: 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: 10442916
• Report Number: 1221934-2020-02285
• Device Sequence Number: 17166916
• Product Code: FCW
• UDI-Device Identifier: 00851455007812
• UDI-Public: 00851455007812
• Combination Product (Y/N): N
• 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): 08/06/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1