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	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.Device inspection and evaluation, service repair noted the following : externally, the unit is in good condition.Internally, the unit is in good condition.When tested, the unit passed all tests in accordance with the oem (original equipment manufacturer) technical manual.The unit.Was soak tested for 3 days and no error occurred.Service repair noted the customer specified fault unconfirmed.When tested, the unit passed all tests in accordance with the oem technical manual.The unit was soak tested for 3 days and no error occurred.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that the device cuts out in mid use.The issue occurred during a therapeutic fess (functional endoscopic sinus surgery).According to the doctor (user), the operation was abandoned as the machine cuts out and could not be used and that the only problem is that the patient will need to return to have the procedure done again at another date.The reporter reported no patient harm or injury and no medical intervention reported as a result of the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 7 years since the device was manufactured.Based on the results of the investigation, it is likely that the reported phenomenon was caused by user error of the device.A definitive root cause cannot be identified.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
• Manufacturer Contact: brian motter ; 2925 appling rd; bartlett, TN 38133 ; 4848965250
• MDR Report Key: 14767136
• Report Number: 1037007-2022-00011
• Device Sequence Number: 14978947
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown