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

Model Number	MDCONS100
Medical Device Problem Codes	Defective Device (2588); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device inspection determined that the touch screen stay gray and buttons does not respond due to faulty rtc board.In addition, monopolar test was found intermittent due to faulty safety board and cable.In addition, minor scratches and dents were observed on the housing unit.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings the reported failure was due to faulty rtc board and faulty safety board and cable attributed to electronic component failure.
Event or Problem Description
It was reported that during an asset return inspection the device was observed with touch screen stays gray and does not respond.There was no patient involvement on this event.No user injury reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the legal manufacturer.Upon evaluation of the device, it was noted that there was damage to the cable from the rtc board to the rf board, touch screen stayed gray and the buttons were not responding along with a monopolar error.There were no other abnormalities noted in the inspection other than normal wear and tear of the device, minor scratches and dings on the housing.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product with serial number (b)(6) was manufactured on 04feb2016 within specification.An investigation was completed by the oem and determined that there is no processing related cause for this failure mode.The root cause has been determined to be an electrical short in the handpiece that will short out and or damage the rtc board located within the console.The root cause for the touchscreen failure is the rtc board short as well.There has been an investigation to address the failures and it has been deemed effective.This product was manufactured before the implementations of the corrections and therefore display issues that have already been addressed in the investigation.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: 11189338
• Report Number: 1037007-2021-00010
• Device Sequence Number: 19691366
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 12/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1