Tricera™ Handpiece, Autoclavable R-10023Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00859273007236), received between May 11, 2022 and Mar 10, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Sparking; Sparking

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE THREW SPARKS WHEN COMING INTO CONTACT WITH OTHER METAL AND THEN IT STOPPED WORKING. THERE WAS NO PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559377 ↗
• MalfunctionSep 19, 2024Difficult to Remove; Failure to Cut; Difficult to Remove; Failure to Cut

  IT WAS REPORTED THAT BEFORE SURGERY WHEN THE DEVICE WAS PLUGGED IN TO TEST IT PRIOR TO PATIENT USE, THE CAUTERY WAS NOT WORKING, NOT CUTTING. THE STERILIZATION CAP CAN 'T BE REMOVED WITHOUT PUTTING IT IN A VICE. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THERE WERE NO METAL WIRES EXPOSED OUTSIDE OF THE DEVICE UPON ARRIVAL, THE EXPOSED WIRE WAS FOUND AFTER DISASSEMBLY TO FURTHER INVESTIGATE THE FAILURE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260146 ↗
• InjuryOct 30, 2023Overheating of Device; Patient Device Interaction Problem; Overheating of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE 3 IN 1 SHAVER OVERHEATED AND BURNED THE PATIENTS ARM. THE PATIENT HAD A BURN IN THE SHAPE OF THE SHAVER ON THEIR ARM. THERE WAS NO DELAY IN THE PROCEDURE. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 18030403 ↗
• InjuryOct 13, 2023Overheating of Device; Patient Device Interaction Problem; Overheating of Device; Patient Device Interaction Problem

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 17931466 ↗
• MalfunctionSep 8, 2022Electrical /Electronic Property Problem; Mechanical Problem; Smoking; Suction Problem; Sparking; Electrical /Electronic Property Problem; Mechanical Problem; Smoking; Suction Problem; Sparking

  IT WAS REPORTED THE DEVICE WASN'T WORKING CORRECTLY AND THE SUCTION WAS OFF, SO THEY PULLED IT OUT OF THE PATIENT AND HIT THE SHAVER MODE TO CHECK IT OUT. THE DEVICE SPARKED WHILE OSCILLATING. THE HANDPIECE WAS SWITCHED OUT AND EVERYTHING WORKED GREAT AFTER THAT AND PATIENT WAS NOT HARMED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385948 ↗
• MalfunctionMay 11, 2022Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE RF FUNCTION STOPPED WORKING IN THIS HANDPIECE DURING THE MIDDLE OF THE SURGERY AND THE DOCTOR WAS NOT ABLE TO USE ABLATION OR COAGULATION. NO HARM OR DELAY REPORTED. EVALUATION OF THE DEVICE LATER FOUND THAT THE PCBA AND SURROUNDING RTV WAS FOUND TO BE BURNT AND THE SURFACE ON THE ELECTRODE RING ALSO SHOWED EVIDENCE OF BURNING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14357068 ↗