MAUDE Adverse Event Report: TTBIO CORP. ACCLEAN ULTRASONIC SCALER

Model Number ACCLEAN ULTRASONIC SCALER

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

Patient Problem Burn(s) (1757)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

A 33 year old hygiene assistant was cleaning the room following a hygiene appointment.When she picked up the insert she received a burn on her finger.The assistant did not need further medical attention, but item has potential to burn patients or other staff members.Both items are extremely hot after use.This happened on (b)(6) 2023 at 11:30 a.M.

Event Description

A 33 year old hygiene assistant was cleaning the room following a hygiene appointment.When she picked up the insert she received a burn on her finger.The assistant did not need further medical attention, but item has potential to burn patients or other staff members.Both items are extremely hot after use.This happened on (b)(6) 2023 at 11:30 a.M.

• Brand Name: ACCLEAN ULTRASONIC SCALER
• Type of Device: 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: 17928480
• MDR Text Key: 325574587
• Report Number: 3010364969-2023-00006
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female