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

Model Number ACCLEAN ULTRASONIC SCALER

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 08/18/2023

Event Type  Injury  

Event Description

Dr.(b)(6) reports that the cavitron was not working for them.They had two hygienists that have burned themselves while using the cavitron units.

• Brand Name: ACCLEAN ULTRASONIC SCALER
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 17799575
• MDR Text Key: 324050152
• Report Number: 3007007357-2023-00010
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/22/2023

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
• Device Operator: Health Professional
• Device Model Number: ACCLEAN ULTRASONIC SCALER
• Device Catalogue Number: 570-2771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2023
• Distributor Facility Aware Date: 08/23/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female