InjuryKMW
S-16
Received Jul 14, 2026
Report 3003755849-2026-00003 · MDR key 25816055
Device
Product problems
- Temperature Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
FAULT DESCRIPTION: THE RETAINING RING AND THE COVER PLATE OF THE BALL BEARING HAVE COME LOOSE. THESE COMPONENTS RUBBED AGAINST THE BEARING SLEEVE, CAUSING IT TO OVERHEAT. THE FAULT IS MOST LIKELY DUE TO A LACK OF MAINTENANCE AND/OR CARE OF THE PRODUCT.
Description of Event or Problem
DOCTOR WAS REMOVING WISDOM TOOTH USING HANDPIECE. WHEN HE WENT TO LOWER RIGHT SIDE, HE NOTICED THAT THE PATIENTS LIP TURNING RED. HANDPIECE LOWER PORTION THAT ENGAGES THE DRILL WAS OVERHEATING AND BURNT PATIENTS LIP.