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	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection of the device confirmed the reported issue.The device was tested and would not recognize handpiece, no activation due to a faulty rtc board.The device was found with old software version and needs to be upgraded along with the card edge board.Minor scratches and dents on housing were observed.Based on evaluation findings the reported failure was found to be due to faulty rtc board attributed to electronic component failure.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 at the beginning of a septorhinoplasty procedure the device will show green when they press the foot pedal however, it goes out right away and no activation to the handpiece was observed.There was an approximately 20 minutes delay into the procedure.The intended procedure was completed using an alternate method with different device.The serial number used 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 investigation.The original equipment manufacturer (oem) performed review of the device history record and 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 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: 11254732
• Report Number: 1037007-2021-00015
• Device Sequence Number: 3582648
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/07/2021

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: JC987677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/07/2021
• 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: LIGHT SOURCEVIDEO SYSTEM