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

Model Number	MDCONS100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a post-market clinical follow-up (pmcf) survey, the diego elite was used for soft tissue shaving of the head and neck.The diego elite performed adequately to cut, coagulate, drill, debride, and remove tissue for bone and soft tissue.The following adverse events were observed: bleeding: the bleeding occurred 2 to 7 days post procedure and the patient was re-hospitalized.The patient made a partial recovery to baseline.There were known comorbidities that may have attributed to the bleeding.Mucosal injury: the mucosal injury occurred 1 to 24 hours after the procedure and was managed clinically with additional medication.The patient made a full recovery to baseline at the time of hospital discharge.There were known comorbidities that may have attributed to the mucosal injury.Nasal symptoms: nasal symptoms occurred 8 to 14 days after the procedure requiring rehospitalization and additional medication.The patient made a partial recovery to baseline.There were known comorbidities that may have attributed to the nasal symptoms.Orbital injury: orbital injury occurred 2 to 7 days after the procedure that required re-hospitalization.The patient made a full recovery to baseline at the time of hospital discharge.There were known comorbidities that may have attributed to the orbital injury.
Additional Manufacturer Narrative
B3: the exact event date is unknown, but the event occurred in august 2023.H6: health effect clinical code: code 4581 was chosen as there were no appropriate terms available for unspecified nasal symptoms and unspecified orbital injury.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.
Additional Manufacturer Narrative
Although the exact age of the patient is unknown, it is known that the age falls within 18-34 years old.The device history record was unable to be reviewed for this device since the serial 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, a specific root cause of the suggested event could not be determined with the information received.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: 18243781
• Report Number: 1037007-2023-00022
• Device Sequence Number: 7191715
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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?: No
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/29/2024
• 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; Required Intervention
• Patient Sex: Male