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

Model Number	MDCONS100
Medical Device Problem Codes	Defective Alarm (1014); Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation confirmed the reported issue.Device inspection determined that the device handpiece is not recognized or running due to a faulty rtc board.Further evaluation determined that there was no monopolar or bipolar output due to damaged t1 of the rf board.In addition, the unit was observed with minor scratches and dents on the housing.The software needs to be upgraded.The device was placed in return stock inventory.Customer device was replaced.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that the device was observed to be not functioning as intended.The issue was first observed at the beginning of an unspecified procedure.There was a delay in the procedure however the intended procedure was completed using another device.Serial: (b)(4) was used to complete the procedure.There was no patient harm or impact reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor the field performance of this device.

• 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: 11189405
• Report Number: 1037007-2021-00011
• Device Sequence Number: 3433377
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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
• Device Lot Number: JC926059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1