MAUDE Adverse Event Report: TTBIO CORP. Henry Schein; Ultrasonic Scaler

Model Number	Acclean Ultrasonic Scaler
Medical Device Problem Codes	Vibration (1674); Power Problem (3010)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This vmsr report summarizes one malfunction event.It was stated on (b)(6) 2026, patients have complained that the scaler, acclean ultrasonic scaler, (b)(4), is too strong and painful.

• 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: 50081743
• Report Number: 3010364969-2026-00005
• Device Sequence Number: 10253566
• Product Code: ELC
• UDI-Device Identifier: 00304040155837
• UDI-Public: (01)00304040155837
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201317
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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?: Yes
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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: 35 YR
• Patient Sex: Female