MAUDE Adverse Event Report: GYRUS ACMI, INC. DIEGO POWERED CONSOLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	70338000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2023
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 device adequately drilled the soft tissue.A mucosal injury occurred within 2 to 7 days post procedure that required a re-hospitalization.The patient made a partial recovery to baseline.There were no known co-morbidities that may have attributed to the mucosal injury.
Additional Manufacturer Narrative
The device is not being returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

• Brand Name: DIEGO POWERED CONSOLE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• 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: 18243745
• Report Number: 1037007-2023-00021
• Device Sequence Number: 6582449
• Product Code: ERL
• UDI-Device Identifier: 00821925011441
• UDI-Public: 00821925011441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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: 70338000
• 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
• Initial Report FDA Received Date: 11/30/2023
• 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