MAUDE Adverse Event Report: TTBIO CORP BRASSELER BRIO 440 HIGHSPEED HANDPIECE

Model Number	BRIO 440
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Back cap came off and turbine dislodged from the handpiece during procedure; patient suffered lower right cheek abrasion.
Event or Problem Description
Back cap came off and turbine dislodged from the handpiece during procedure; patient suffered from lower right cheek abrasion.

• Brand Name: BRASSELER BRIO 440 HIGHSPEED HANDPIECE
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 21657675
• Report Number: 3007007357-2025-00002
• Device Sequence Number: 18012446
• Product Code: EFB
• UDI-Device Identifier: 00887919774594
• UDI-Public: (01)00887919774594
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025
• Report Date (Section F): 04/02/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: BRIO 440
• Device Catalogue Number: 5026059U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2025
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/02/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 04/02/2025