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

Model Number ACCLEAN ULTRASONIC SCALER

Device Problems Insufficient Information (3190); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 02/21/2023

Event Type  Injury  

Event Description

During a routine prophy with some scaling and cavitron use, the black handpiece where the cavitron tip is inserted caused a pizza like burn to the right inside part of patient's mouth.

• 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: 16588533
• MDR Text Key: 311734249
• Report Number: 3007007357-2023-00002
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2023
• Distributor Facility Aware Date: 02/22/2023
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female