MalfunctionEFB
Midwest® T1 Energo 1:5 L
Received Jul 31, 2026
Report 9614977-2026-00129 · MDR key 50100201
Device
Generic name
Handpiece, Air-powered, Dental
Manufacturer
Sirona Dental Systems GmbhProduct problems
- Overheating of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a Midwest® T1 Energo 1:5 L overheated; no injury resulted.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, is must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21CFR Part 803. Product return is requested, though has not been returned as of this report. Evaluation results will be submitted as they become available.