Related Experiment Video
Updated: Mar 25, 2026
Roughness Impact of Piezoelectric Dental Scaler on Two Distinct Flowable Composite Filling Materials
Published on: January 10, 2025
Adverse events associated with ultrasonic scalers: A manufacturer and user facility device experience database
Rajagopal Athmarao Thennukonda1, Bhavani Rekha Natarajan
1Department of Dentistry, Madurai Medical College and Hospital, Madurai, Tamil Nadu, India.
Background:
The present study was conducted to determine the frequency and type of adverse events (AEs) associated with ultrasonic scaler reported to the Food and Drug Administration manufacturer and user facility device experience (MAUDE) database.
Materials And Methods:
The authors reviewed the ultrasonic scaler units (USU) related AEs reported to MAUDE from October 1, 1995, to September 31, 2015. Analyses of details collected are presented.
Results:
MAUDE received a total of 667 unique USU-related AE reports. Of 667 cases, MAUDE classified 628 instances (94.2%) as malfunction 27 (4%) as injurious, 10 (1.5%) as others, and 2 (0.3%) claiming the use of USU as cause of death. Of the 667 cases, 511 (76.6%) were used for endodontic application, and 147 (22%) as scaler applications. In 512 (76.8%) instances, there was separation of the tips, posing danger to patients or users, and 112 (16.8%) instances of overheating, 12 (1.8%) instances of breakage, and electrical issues in 8 (1.2%) instances. These AE resulted in 19 instances of thermal injury, 2 suspicious deaths, and hearing loss in 3 cases. In 4 cases, patient swallowed broken parts requiring additional medical care.
Conclusions:
Use of USU, a Class 2 device without exemption, carries a degree of risk to patient's safety, if not properly used. As of today, MAUDE data is the only reliable source of AE until another database or such study is carried out. Certain AE that has been largely anecdotal, such as hearing loss has been reported in this study. The findings from study reiterate that more in-depth analysis of AE of USU is needed. Until then operator needs to take all precautions to avoid AE when using USU.
More Related Videos
06:36Effects of Mechanical Methods Used in Peri-implantitis Treatment on Implant Surface Decontamination and Roughness
Published on: March 14, 2025
05:50Author Spotlight: Point-of-Care Ultrasound for Gastric Content Assessment and Risk Stratification in Perioperative Care
Published on: September 22, 2023
Related Concept Videos
01:17Ultrasonography
During an ultrasonography procedure, a handheld device called...
01:26Tonsillitis II: Management
01:24Imaging Studies II: Ultrasonography
01:20Ultrasound I: Abdominal Ultrasonography
Abdominal ultrasonography, commonly known as abdominal ultrasound, is a vital, non-invasive medical imaging technique widely used in healthcare.
Procedure:
This diagnostic tool allows the clinician to visually inspect internal structures within the abdomen, including vital organs such as the liver, gallbladder, pancreas, kidneys, and spleen.
The abdominal ultrasound process begins with applying a special gel to the patient's skin over the abdomen. This gel enhances the...
01:14Imaging Studies I: CT and MRI
Description of the Procedures
Computed Tomography (CT) scan:
Computed Tomography (CT) scans use X-ray technology to generate detailed images of bones, organs, and tissues. During the scan, the patient lies on a moving table...