Ultrasonic Device Complications in Endodontics: An Analysis of Adverse Events From the Food and Drug Administration Manufacturer and User Facility Device Experience

Conclusions The frequency, root causes, and economic costs of ultrasonic tip device breakage remain largely unstudied. Ultrasonic endodontic device–related adverse events and patient injuries occurring within clinical practice may be underreported at the present time. Consequently, the risks and ultimate impacts to patients from ultrasonic endodontic device breakage, malfunction and unknown cause-related adverse events, and patient injuries during their clinical usage remain largely unknown at the present time. Eight of the 10 patient injury–related reports made to the FDA MAUDE database during the period under study, containing descriptions of varying degrees of injury severity, were associated with an irrigation-related device.
Source: Journal of Patient Safety - Category: Health Management Tags: Original Studies Source Type: research