MAUDE Adverse Event Report: TTBIO CORP. ACCLEAN ULTRASONIC SCALER

Model Number	ACCLEAN ULTRASONIC SCALER
Medical Device Problem Codes	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	Malfunction
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.
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.

• Brand Name: ACCLEAN ULTRASONIC SCALER
• Common Device Name: SCALER
• Manufacturer (Section D): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f., no.7, 6th road; industry park; taichung, 40755
• MDR Report Key: 17928480
• Report Number: 3010364969-2023-00006
• Device Sequence Number: 6401519
• Product Code: ELC
• UDI-Device Identifier: 00304040155837
• UDI-Public: 0100304040155837
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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?: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female