MAUDE Adverse Event Report: DEPUY MITEK LLC US EVOLUTION4K; VIDEO IMAGE SYSTEM

Model Number	Evo4K220
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
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.Investigation summary: according to the information provided, it was reported that the device was unable to recognize the video signal.In addition, the channel selection icon and the video input tab were not visible.The complaint device was received and evaluated by the supplier.After careful disassembly and review, it was determined that a small fiber particle of undefined material was found in the motherboards pcie slot.This was identified as the root cause of the failure reported, causing an intermittent connection between the pcie slot and the video acquisition pcb.Therefore the complaint was confirmed.No other anomalies were noted.A manufacturing record evaluation was performed for the finished device [000092] number, and no non-conformance's were identified.Further investigation revealed that this was probably a result of a rework of this lot number.As a corrective action, the production team will be trained (trng20-043) to avoid similar issues.Depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via email that during a demo the evo4k device was unable to recognize the video signal coming from the purevue ccs via a quad 3g-sdi cable connection.Further, the channel selection icon that typically appears in the top right hand corner of the live video screen (img_1128) was not visible.The ¿video input¿ tab within the system settings was also not visible.To troubleshoot, the device was restarted manually.The device was then reset using a factory reset through the settings menu.This was attempted twice.Additional cable connections were tried including single 3g-sdi connection from the purevue ccs to each of the 4 sdi-in ports on the evo4k device.None of these cable connections fixed the issue.

• Brand Name: EVOLUTION4K
• Common Device Name: VIDEO IMAGE SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9714439
• Report Number: 1221934-2020-00584
• Device Sequence Number: 408715
• Product Code: FCW
• UDI-Device Identifier: 00817613020543
• UDI-Public: 00817613020543
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/13/2020

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 Model Number: Evo4K220
• Device Catalogue Number: 242326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1