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	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via complaint submission tool that before surgery, after starting pure vue (rad32" 4k/uhd medical display), the screen flickered.Taking away camera connection didn't help.Shut down and restart of ccs (all-in-one ccu+light row) without camera connection didn't help.Only restart of hole pure vue system without camera connection solved flickering.It occurs when camera is inserted in ccs before start of pure vue.
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 :according to the information provided, it was reported that before surgery, after starting pure vue (rad32" 4k/uhd medical display), the screen flickered.Taking away camera connection didn't help.Shut down and restart of ccs (all-in-one ccu+light row) without camera connection didn't help.Only restart of hole pure vue system without camera connection solved flickering.It occurs when camera is inserted in ccs before start of pure vue.The complaint device is not being returned due to they still use it; therefore, unavailable for a physical evaluation.However a photo was provided.The photo provided by the customer, only showed information about the serial number of the device.The photo do not provide enough evidence to determine root cause;therefore, this complaint cannot be confirmed.Hands on analysis should provide the evidence necessary to confirm the root cause.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: 10182056
• Report Number: 1221934-2020-01595
• Device Sequence Number: 16703027
• Product Code: FWC
• 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): 06/04/2020

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?: Yes
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 09/16/2020
• Patient Sequence Number: 1