MAUDE Adverse Event Report: DEPUY MITEK LLC US IMAGE MANAGEMENT SYSTEM

Model Number EVO4K220

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 09/15/2021

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 sales rep in (b)(6) that during a demonstration, it was observed that the image management system- evolution 4k device could not display an image in the live video menu after the camera was connected to the generator.There was no procedure nor patient involvement reported.No additional information was provided.

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.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.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that during the demo, after connected camera to generator, images cannot be displayed in the live video menu.It will be repaired in china cts, not return to opco.Per service manual operational and diagnostic, the reported failure was confirmed.During evaluation, the turned unit on and lcd display are damaged and only back light works (screen is spider webbed from too much pressure applied), connected display monitor and hooked up dvi cable, no video input options show up on the display.The root cause is related to the capture card failed.The certificate of analysis and certificate of compliance for this manufactured lot is attached to this complaint file.There were no non-conformances or deviations for this lot on the coc.

• Brand Name: IMAGE MANAGEMENT SYSTEM
• 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: 12706518
• MDR Text Key: 278834559
• Report Number: 1221934-2021-03156
• Device Sequence Number: 1
• Product Code: LMB
• UDI-Device Identifier: 00817613020987
• UDI-Public: 00817613020987
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1