EM-19 Electric Motor 30185000Recalls & reported problems
W & H Dentalwerk Bürmoos GmbH · Electric Motor with cable 1.8m · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J021301850001), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Temperature Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Temperature Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2023Temperature Problem; Temperature Problem
PATIENT WAS HAVING REMOVAL OF HER WISDOM TEETH, WHICH REQUIRES REMOVAL OF BONE AND SECTIONING OF TEETH WITH A HIGH-SPEED ROTARY INSTRUMENT. WE USE A SURGICAL STRAIGHT HANDPIECE WITH A MOTOR THAT RUNS AT STANDARD 50,000 RPM (MFR: W&H ELCOMED). A 702 CARBIDE BUR WAS USED WITH COPIOUS NORMAL SALINE IRRIGATION. I ALWAYS USE MY FINGERS TO HOLD THE LIP / CHEEK OUT TO NOT ONLY GET MORE LIGHT INTO THE FIELD, BUT ALSO TO AVOID TRAUMA FROM THE BUR. A FEW MINS AFTER SECTIONING TOOTH #47, MY ASSISTANT NOTICED A DEEP (3RD DEGREE) BURN TO THE LEFT LIP COMMISSURE, EVIDENTLY AS A RESULT OF THE SHAFT OF THE HANDPIECE HAVING CONTACT WITH TISSUES WHILE IN USE. THIS IS EXPECTED. WE USE SURGICAL HANDPIECES EVERYDAY, BUT I HAVE NEVER ENCOUNTERED A BURN LIKE THIS BEFORE. I DID NOT FEEL ANY HEAT GENERATED BY THE HANDPIECE ITSELF, AND WE DIDN'T ACTUALLY EVEN SEE THE BURN UNTIL A MIN OR 2 LATER, ALMOST AS IF IT WAS A DELAYED REACTION TO WHATEVER HEAT OR VIBRATION WAS BEING GENERATED BY THE HANDPIECE. TO CLARITY IT WAS NOT THE BUR, BUT RATHER THE SHAFT OF THE HANDPIECE VS, MOTOR ITSELF. I COULDN'T TELL WHICH WAS RESPONSIBLE. THE BURN WAS FULL THICKNESS INTO MUSCLE. THOUGH THERE WAS NOT EVEN ANY BLEEDING FROM
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 17212315 ↗
Other Controller, Foot, Handpiece And Cord devices
- X-Smart IQ XSIQEM1BSKTulsa Dental Products LLC · Controller, foot, handpiece and cord2 reports
- S-NW CAN-Bus 30264000W & H Dentalwerk Bürmoos GmbH · Controller, Foot, Handpiece And Cord1 report
- X-Smart IQ XSIQEM1HSPTulsa Dental Products LLC · Controller, foot, handpiece and cord1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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