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

Model Number	MDCONS100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age range per initial reporter is 18-34 years of age.The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The user reported in a post market clinical follow up study that when using a diego elite during soft tissue drilling, a patient experienced mucosal injury within or equal to an hour post procedurally.The mucosal injury was managed with re-hospitalization.It was also reported that the device did not drill adequately due to technical issues, which was described as "nessuno" without other details.The physician proceeded without use of the device or any other device for drilling.The event occurred during a therapeutic procedure (adenoidectomy/tonsillectomy) and was completed without using this device.The patient fully recovered to baseline at time of hospital discharge.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, since the device was not returned to olympus, a physical device evaluation was not performed.Therefore, the root cause of the reported event could not be determined.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.
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).

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: ELECTROSURGICAL 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: 18293004
• Report Number: 3003790304-2023-00446
• Device Sequence Number: 17854230
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Study,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 03/15/2024; 06/21/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/18/2024; 06/21/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male