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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection of the device found that the reported issue was not able to be duplicated.Upon testing, the unit passed all functional test with no issues observed.All output powers are within specifications and passed the leakage current test.Minor dents and scratches were observed on the housing unit however the physical defects found did not affect the functionality of the device.Based on evaluation findings the reported issue was not confirmed as the device passed all required testing with no issue observed.Root cause of the reported issue by the user is unknown as no device issue found during device testing.
Event or Problem Description
It was reported that during preparation for use the device is not functioning as intended.The bipolar function does not recognized by the console.There was no patient involvement on this event 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.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.Based on the legal manufacturer¿s investigation, it is likely there was an issue with the hand piece, and not with the console, as reported.The hand piece was not returned for evaluation so this cannot be confirmed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response/updates and legal manufacturer conclusion.Further communication with the customer conveyed the following information: the error occurred several different times on several different days.Customer were able to rule out the handpiece as being the problem.The machine was rebooted almost every time and the bipolar function grayed out.Their foot pedal is fairly new and all the cords seem to be in good condition.The device is used daily.It is only when they need the bipolar function.The blade they use is the bb2000sa.A new blade was even tried from another lot.No alarms were received.Since they have had the loaner device they have not had any issues.Further communication with the customer conveys that the issue may have been as a result of the mdcons100 damages from their experience.However, physical evaluation and functional testing from the olympus service team was unable to discover issues with the returned console.As a result, the issues experienced from the customer may have been as result of damages to the handpiece or accessories.None of the customer handpiece or accessories were returned.Olympus will continue to monitor complaints for 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: 11232508
• Report Number: 1037007-2021-00014
• Device Sequence Number: 14468550
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 02/26/2021

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: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/03/2021; 02/22/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/17/2021; 02/26/2021
• 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: CONSOLE GENERATOR