MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE

Model Number	MDCONS100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Evaluation determined that the reported issue was not confirmed.The device was tested and passed all functional testing with no issues observed.All output powers are within specifications and passed the leakage current test.Unrelated to the reported issue, dents and minor scratches were observed on the housing unit and does not affect the functionality of the device.Based on evaluation findings the reported issue was not confirmed as the device passed all functional testing and no issues were observed.
Event or Problem Description
It was reported that in the middle of a sinus surgery procedure the device was observed to be not functioning.The user is having a long boot and activation issues.The intended procedure was completed without any delay.The same device was not used to complete the procedure.The serial number of the device used to complete the case was not provided.There was no patient harm or injury reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: g4, g7, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been nearly 7 years since the subject device was manufactured.An investigation was completed by the original equipment manufacturer and determined that there was no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be a need for an updated version of hardware to combat the diego elite console from loading and activating slowly.Since the software and card edge board were all updated with current versions, an outdated hardware will cause this issue of loading and activation in a timely manner.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: MULTIDEBRIDER POWER CONSOLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11166006
• Report Number: 1037007-2021-00009
• Device Sequence Number: 17017753
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: MDCONS100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1