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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.Inspection found the reported issue was confirmed.The ¿power on test¿ found the power button works intermittently.Further testing noted that the control board needs to be replaced however, when tried to test with control board, rf board and rtc board, the testing failed.The service center noted that further troubleshooting with led front panel will be conducted.Based on evaluation findings the reported issue was confirmed.The investigation is ongoing, this report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that the device is not activating with the handpiece.The screen will not activate and the button are not responding.The pump has reduce function.It happens intermittently.The issue found during preparation for use.There was no patient involvement reported due to the event.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.An investigation was completed by the oem (original equipment manufacturer) and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be a need for preventative maintenance for the misalignment of the touchscreen buttons and power switch.The touchscreen buttons and power button can become worn over time if used frequently and or inadequately.The damages incurred may have been a result of frequent or mishandling usage from the customer.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: 11750433
• Report Number: 1037007-2021-00033
• Device Sequence Number: 1296965
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: No Information
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE