MAUDE Adverse Event Report: DEPUY MITEK LLC US 242326; EVOLUTION4K

Model Number	Evo4K220
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/17/2019
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 email that during an unknown procedure the mitek video cart was set up and when the light cord and camera were plugged in, the monitor and evo4k started to display a number of colors in static format.The camera cord was pulled out and plugged back in - same static picture displayed.A replacement camera was used and displayed the same result.The monitor was powered off/on and the static color scheme was still present.Finally, the ccs was powered off while confirming all wiring in the back was correct and connected properly.The ccs was powered back on and camera/light cord plugged back in.Once again the static color scheme reappeared.The competitive tower, in the room, was powered on and was used for video on the case.Our pump and shaver continued to be used from the purevue tower.There was a minimal delay (under 3 minutes) to connect new video.The surgeon was able to successfully complete the procedure with no patient consequences.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: correction: upon complaint review, it was determined that mfr# 1221934-2020-00224 is a duplicate of mfr# 1221934-2020-00249.Reference mfr # 1221934-2020-00249 for all further reporting regarding this event.

• Brand Name: 242326
• Common Device Name: EVOLUTION4K
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9595908
• Report Number: 1221934-2020-00224
• Device Sequence Number: 2387519
• Product Code: FCW
• UDI-Device Identifier: 00817613020543
• UDI-Public: 00817613020543
• 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): 12/17/2019

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?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1