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

Model Number	MDCONS100
Medical Device Problem Codes	Output Problem (3005); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a therapeutic fess (functional endoscopic sinus surgery) procedure; the unit was functional throughout the procedure but malfunctioned at the end.According to the reporter, the suction button non functional from the console , handpiece and foot pedal then failed towards end of surgery.The surgeon completed the surgery using conventional surgical techniques and the surgery was successful.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the olympus medical safety board (mso) evaluation, this is a severity level 2 failure.There is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.The device was not returned within the appropriate time frame.Due to no device return, a physical evaluation could not be performed on the console.If the console were returned at a later date, the complaint and investigation shall be updated appropriately.The definitive root cause of the console suction button not working could not be determined due to no evaluation.However, per diego elite functional checklist, the console suction button is pressed to activate the suction console to ensure that it activates and is able to be turned off per step 12 and 13.Per diego elite instruction for use (ifu): ¿inspect the external portion of the suction module for damage, wear, and missing parts.Suction modules that appear to have been dropped or otherwise damaged should be checked thoroughly to verify correct operation and performance.Any deficiencies should be evaluated and repaired immediately.¿ it is unlikely for the console to have left the facility without a functional suction button.Therefore, the damages may have been incurred during transportation or customer use.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
• Manufacturer Contact: brian motter ; 2925 appling rd; bartlett, TN 38133 ; 4848965250
• MDR Report Key: 14749819
• Report Number: 1037007-2022-00010
• Device Sequence Number: 2123067
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2022

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECEFOOTSWITCH (PEDAL)
• Patient Sex: Unknown