S-11 surgical handpiece 1:1 30056000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J021300560001), received between Jun 27, 2023 and Feb 25, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Temperature Problem; Temperature Problem

  DURING A SURGERY (WISDOM TOOTH) CORONORADICULAR SECTION WITH BULB BUR ON THE 48 TOOTH INCLUDED, A PATIENT WAS DEEPLY BURNED ON THE 3RD LEVEL (LOWER LIP). RISK OF PERMANENT INJURY WITH AESTHETIC DAMAGE FOR THE PATIENT. UPDATE ON 06/02/2025: THE SURGEON WHO PERFORMED THE SURGERY ON THE VICTIM CONFIRMED THAT THE INJURY IS REVERSIBLE. A COSMETIC SURGERY IS NECESSARY TO REMEDY THE INJURY AND THERE IS NO DOUBT THAT IT WILL COMPLETELY SCAR.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21457856 ↗
• 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: Burn(s)

  MAUDE report 17212302 ↗