MAUDE Adverse Event Report: DEPUY MITEK LLC US IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K

Model Number EVO4K220

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the affiliate in (b)(6) that the image management system device had software issue; and that there was no picture signal.There was no procedure nor patient involvement reported.No additional information was provided.Software issue.No.

• Brand Name: IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
• Type of Device: IMAGE MANAGEMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12691833
• MDR Text Key: 278217436
• Report Number: 1221934-2021-03116
• Device Sequence Number: 1
• Product Code: LMB
• UDI-Device Identifier: 00817613020987
• UDI-Public: 00817613020987
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVO4K220
• Device Catalogue Number: 242326
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1