MAUDE Adverse Event Report: TTBIO CORP. HENRY SCHEIN; ULTRASONIC SCALER

Model Number	ACCLEAN EASY GRIP XL TRIPLE BEND SLIM
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Sensitivity of Teeth (2427)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of product gets hot and produces steam.No patient injuries reported.
Event or Problem Description
Tip of product gets hot and produces steam.No patient injuries reported.

• Brand Name: HENRY SCHEIN
• Common Device Name: ULTRASONIC 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: 19432694
• Report Number: 3010364969-2024-00011
• Device Sequence Number: 12860609
• Product Code: ELC
• UDI-Device Identifier: 00304040165126
• UDI-Public: 010030404016512610231013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACCLEAN EASY GRIP XL TRIPLE BEND SLIM
• Device Catalogue Number: 570-2237
• Device Lot Number: 231013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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
• Patient Sex: Unknown