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

Model Number	MDHP100S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact age of the patient is unknown, but it is known the patient was 18 to 34 years of age.The event date was in may 2023, however the exact day is unknown.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
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 had technical issues and did not adequately coagulate the bone.The procedure was continued without use of the device.An orbital injury occurred within 2 to 7 days after the procedure in which additional medication was used for clinical management.The patient was discharged home fully recovered.The patient had comorbidities that may have contributed to the orbital injury.
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 subject device was not returned to olympus, an evaluation could not be performed.Therefore, a definitive root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: MULTIDEBRIDER HANDPIECE, STRAIGHT
• 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: 18264025
• Report Number: 1037007-2023-00025
• Device Sequence Number: 20805960
• Product Code: ERL
• UDI-Device Identifier: 00821925027756
• UDI-Public: 00821925027756
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: MDHP100S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: 03/21/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 03/22/2024
• 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: Required Intervention
• Patient Sex: Male