S-12 surgical handpiece 1:2 30061000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI J021300610001), received between Feb 1, 2019 and Apr 20, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Temperature Problem

  THE HANDPIECE WAS USED WITH COPIOUS SALINE IRRIGATION (40%) ATTACHED TO SURGICAL HANDPIECE IRRIGATION INPUT. SIDE OF HANDPIECE (NOT BUR) OVERHEATED AND BURNED PATIENTS'S FACE/LIP DURING DECORONATING CROWN OF TOOTH #18. HANDPIECE OVERHEATED TO HIGH LEVEL CAUSED 2ND DEGREE BURN TO PATIENT ALONG VERMILLION BORDER AND ONTO SKIN OF CHIN. COPIOUS SALINE IRRIGATION WAS UTILIZED/ATTACHED TO HANDPIECE; HOWEVER, OVERHEATING WAS A RESULT OF OVERHEATING/MALFUNCTION OF THE BODY OF THE HAN.

  Patient problems: Burn(s)

  MAUDE report 24924982 ↗
• InjuryApr 16, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  DURING A DENTAL SURGICA TREATMENT THE INSTRUMENT GOT HOT AND IT ENDED UP IN BURNING THE PATIENT'S LIP (2ND DEGREE). THE INJURY IS REVERSIBLE AND THE PATIENT IS UNDER MONITORING. AFTER EVALUATION OF THE SUSPECT DEVICE IT CAME OUT THAT THE ADVERSE EVENT OCCURED DUE TO WRONG LUBRICATION OF THE INSTRUMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8517118 ↗
• InjuryFeb 1, 2019Overheating of Device

  THE END-USER STATED THAT THE TIP OF THE HANDPIECE S-12 GOT HOT AND BURNED THE PATIENT. ALSO THE ASSISTANT GOT BURN MARKS AFTER TOUCHING THE HANDPIECE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8295675 ↗