EZ Clean 0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10614559100080), received between May 9, 2018 and Sep 15, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fire” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427936 ↗
• MalfunctionJan 20, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A VATS PROCEDURE THE TIP, WHEN PLACED ON A COMPETITIVE PENCIL, CAUGHT FIRE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13308584 ↗
• MalfunctionJan 13, 2022Fire; Arcing of Electrodes; Fire; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A COVIDIEN CAUTERY HAND CONTROL AND E-Z CLEAN TIP IGNITED WHILE IN USE. PER THE SURGEON, THERE WAS AN ACTUAL FLAME PRESENT. THE SURGICAL TECH REPORTS NO ISSUES WITH REPLACING THE ORIGINAL TIP WITH AN E-Z CLEAN TIP. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252381 ↗
• MalfunctionJun 7, 2019Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CAUTERY PENCIL, CAUGHT FIRE AT THE TIP OF THE HANDPIECE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678673 ↗
• MalfunctionMar 22, 2019Fire; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A MASTECTOMY, THEY WERE USING HARMONIC FOCUS AND MEGADYNE 0012 AT THE SAME TIME. THEY SAW A FLASH OF FLAME. THE PATIENT HAD LARGE AMOUNTS OF "GREASY FAT" BECAUSE SHE WAS MORBIDLY OBESE AND WHILE DISSECTING THE TISSUE, THE TEAM NOTICED PARTICLES 'SPRAYING' MORE THAN NORMAL. THE SURGEON DID INSTRUCT THE RESIDENT TO USE THE BOVIE WHILE SHE USED THE HARMONIC SCALPEL BECAUSE SHE WANTED TO MOVE THE CASE ALONG AND DID NOT KNOW OF ANY ISSUE USING THESE DEVICE SIMULTANEOUSLY. THE TEAM DID NOTICE A BRIEF 'FLASH FIRE BALL' ABOVE THE PATIENT AND THE DEVICES. THE PATIENT'S TISSUE DIDN'T APPEAR TO BE AFFECTED AT ALL BY THE BRIEF OCCURRENCE BECAUSE IT WAS ABOVE THE FIELD AND THE TEAM THOROUGHLY INSPECTED THE TISSUE. NO INJURY NOTED. THE TEAM REMOVED THE EQUIPMENT FROM USE. NEW UNITS AND DEVICES WERE OBTAINED FOR CASE COMPLETION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8445897 ↗
• MalfunctionSep 14, 2018Fire; Sparking

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE SURGEON WAS USING A COVIDIEN FT10 ELECTROSURGICAL GENERATOR UNIT (ESU) SERIAL # (B) (4) AND A MEGADYNE BOVIE NEEDLE TIP-LOT #183471 AND ENCOUNTERED A SPARK AND A SMALL FLAME IN THE OPERATING ROOM. STAFF REMOVED THE TIP AND REPLACED IT WITH A REGULAR MEGADYNE BOVIE TIP- LOT# 180191 AND AGAIN ENCOUNTERED SPARKS AND A SMALL FLAME. STAFF REMOVED THE ESU UNIT AND NO ADDITIONAL SPARKS OR FLAME OCCURRED. THE INITIAL UNIT WAS SET AT THIRTY CUT AND THIRTY COAG WHEN THE SPARK OCCURRED. THEN, THE UNIT WAS TURNED DOWN TO TWENTY CUT AND TWENTY COAG WITH THE SAME RESULT. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877669 ↗
• MalfunctionAug 28, 2018Fire; Melted

  IT WAS REPORTED THAT DURING AN OPEN RIGHT FEMORAL ARTERY THROMBENDARTERECTOMY, WHEN THE DEVICE WAS USED TO THE GROIN, THE COATING PORTION STARTED MELTING AND IT MADE A FIRE. OUTPUT LEVEL OF THE ELECTRICAL SCALPEL WAS 40 AND THE SURGEON DISINFECTED THE DEVICE WITH ISODINE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824854 ↗
• InjuryMay 9, 2018Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR HAD PERFORMED AN EXCISION OF THE POST AREA CERVICAL LIPOMA ON (B)(6) 2018. ON A FOLLOW-UP VISIT ON (B)(6) 2018, THE PATIENT REPORTED A WOUND THAT WAS NOT HEALING WELL. THE AREA APPEARED BLACK AND CRUSTY. THE SURGEON FELT THAT THIS WAS A SUB-DERMAL BURN FROM THE CAUTERY THAT WAS USED ON THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 7499343 ↗