MAUDE Adverse Event Report: GYRUS ACMI, INC.¿ MULTIDEBRIDER POWER CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	MDCONS100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the device is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during an endoscopic disc nasal surgery (type iv), nasal septum correction, and inferior turbinate mucosal resection, the subject device suddenly stopped working and the screen would not come up.The device was restarted, but the screen turned rainbow-colored and would not come up.There was no error code generated.The procedure was completed with a non-olympus device after a 1-hour delay.There were no reports of patient harm.The device was inspected prior to use with no issues noted.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to fields h3 and h4.The device was evaluated by olympus, and it was confirmed that the device did not start up properly.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that reported event is caused by an internal component malfunction that prevents the system from starting up properly.However, the cause of the internal component malfunction has not been identified and the specific root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.¿; 2925 appling rd¿; bartlett¿ TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.¿; 2925 appling rd¿; bartlett¿ TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20482964
• Report Number: 3011050570-2024-00443
• Device Sequence Number: 3615463
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/09/2024
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 04/07/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/29/2024; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: SB4090RC/BB4000SC.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian