MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL ALL-IN-ONE CCU+LIGHT ROW; ENDOSCOPIC VIDEO IMAGING SYSTEM

Model Number 242302

Device Problem Intermittent Continuity (1121)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Udi:(b)(4).

Event Description

As reported by the sales rep via email the all-in-one ccu+light row that was just placed at the facility has the following issues, "video signals do not always send.Example, when pressing the buttons on the camera the ccs box intermittently does not send a signal to the purevue screen indicating the button was pressed.Also intermittently the ccs does not send a video signal to the evo4k." no case involved.

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.: investigation summary the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.The sales rep evaluated the device in the facility and found that there was an error in reporting the unit as having a fault.In setting up the unit there were no issues found.It was identified that the user reporting the fault feedback was either inexperienced with the units settings or did have the proper power set at the facility.No manufacturing record evaluation is required as no manufacturer or service related issues were found with the device.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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: ALL-IN-ONE CCU+LIGHT ROW
• Type of Device: ENDOSCOPIC VIDEO IMAGING SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10653499
• MDR Text Key: 210595782
• Report Number: 1221934-2020-02936
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 10886705028702
• UDI-Public: 10886705028702
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242302
• Device Catalogue Number: 242302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Patient Sequence Number: 1