MAUDE Adverse Event Report: TTBIO CORP ASPEN BRIO 440; HANDPIECE

Model Number	ASPEN BRIO 440
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was using the handpiece when the bur came off in the patient's mouth and was swallowed.

• Brand Name: ASPEN BRIO 440
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 15905713
• Report Number: 3007007357-2022-00015
• Device Sequence Number: 5427176
• Product Code: EFB
• UDI-Device Identifier: 00810988030391
• UDI-Public: 00810988030391
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/02/2022
• Report Date (Section F): 12/02/2022

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: ASPEN BRIO 440
• Device Catalogue Number: 9076252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2022
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2022
• 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 Sex: Female
• Date Report Sent to FDA: 12/02/2022