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

Model Number	MDCONS100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
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 powered on successfully when first inspected and always during soak testing.The unit was soak tested for 5 days and no error occurred.Based on evaluation findings, the customer specified fault unconfirmed.When tested, the unit passed all tests in accordance with the oem technical manual.The unit powered on successfully when first inspected and always during soak testing.The unit was soak tested for 5 days and no error occurred.Service repair noted recommended the device is passed to the workshop for full inspection and electrical safety test.The investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that the diego elite console had become extremely hot during procedure and then the device completely powered down.All power was cut out and they have not been able to restart the device.The device have taken out of clinical use.According to the reporter, the procedure had to be abandoned but the patient is fine in terms of health (no injury/infection), only inconvenience of having to go through the procedure again.According to the reporter, the customer was provided a loaner needed for the procedure.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented based on customer response and follow up.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Communication with the customer representative, the following information conveyed : the procedure was functional endoscopic sinus surgery (fess).Device was inspected prior to use and patient being put under ga (general anesthesia).Device was working with no issues reported.Console became hot midway through procedure and stopped functioning.Micro-debrider was removed safely from nose and no negative effects to patient.Procedure was cancelled part way through and patient re-scheduled for completion of surgery.No further information provided.
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 could not be performed because the dhr was not available.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the device inspection, the exact cause of the reported complaint could not be determined.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: 14640095
• Report Number: 1037007-2022-00009
• Device Sequence Number: 5574987
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022

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: 05/16/2022
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 08/04/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/11/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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