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.

• Brand Name: HENRY SCHEIN
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 19386421
• Report Number: 3007007357-2024-00015
• Device Sequence Number: 20601141
• 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): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/23/2024
• Report Date (Section F): 05/23/2024

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2024
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/23/2024