MAUDE Adverse Event Report: TTBIO CORP ACCLEAN ULTRASONIC SCALER; HANDPIECE

Model Number	ACCLEAN ULTRASONIC SCALER
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 33 year old hygiene assistant was cleaning the room following a hygiene appointment.When she picked up the insert she received a burn on her finger.The assistant did not need further medical attention, but item has potential to burn patients or other staff members.Both items are extremely hot after use.This happened on (b)(6) 2023 at 11:30 a.M.
Additional Manufacturer Narrative
Amended the formal investigation report to show evaluation results, root cause of failure, and resulting actions.
Event or Problem Description
A 33 year old hygiene assistant was cleaning the room following a hygiene appointment.When she picked up the insert she received a burn on her finger.The assistant did not need further medical attention, but item has potential to burn patients or other staff members.Both items are extremely hot after use.This happened on 08/16/2023 at 11:30 a.M.

• Brand Name: ACCLEAN ULTRASONIC SCALER
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 17799662
• Report Number: 3007007357-2023-00011
• Device Sequence Number: 12556343
• Product Code: ELC
• UDI-Device Identifier: 00304040155837
• UDI-Public: 0100304040155837
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024
• Report Date (Section F): 01/11/2024
• 2 Devices were Involved in the Event: 1 2

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: ACCLEAN ULTRASONIC SCALER
• Device Catalogue Number: 570-2771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/11/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 01/11/2024
• 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: 33 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/11/2024