Megadyne 0014BNRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559101308), received between Jan 8, 2019 and Nov 11, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081791, K862221); they may or may not involve this specific model.

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 16, 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.

• InjuryNov 11, 2020Arcing of Electrodes; Device Misassembled During Manufacturing /Shipping; Human-Device Interface Problem; Arcing of Electrodes; Device Misassembled During Manufacturing /Shipping; Human-Device Interface Problem

  IT WAS REPORTED THAT WHILE USING THE CAUTERY TIP, THE TIP "ARCHED" AT THE INSULATED TIP BURNING THE PATIENT CAUSING THE SURGERY TEAM TO EXCISE THE BURN. ONE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Burn(s); Burn, Thermal; Scar Tissue

  MAUDE report 10822196 ↗
• MalfunctionJan 8, 2019Fire; Sparking

  IT WAS REPORTED THAT DURING A BILATERAL MASTECTOMY, THE TIP OF THE CAUTERY DEVICE SPARKED A FLAME THAT WAS ABOUT TWO INCHES HIGH. PER THE CUSTOMER, THE FLAME OCCURRED AFTER FIRST USE OF THE CAUTERY DEVICE AND THEN THE TIP WAS SUBSEQUENTLY CHANGED; AFTER THE TIP WAS CHANGED, NO FURTHER INCIDENT WAS OBSERVED DURING THE REST OF THE PROCEDURE. THE CUSTOMER INDICATED THAT THERE WAS NO IMPACT OR ADVERSE EFFECT TO THE PATIENT. NO IMPACT TO THE PROCEDURE WAS REPORTED. NO SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8229145 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081791, K862221. One submission often covers many models, so check the product and lot details in each record.

• Z-0486-2010 · Oct 13, 2009 · Terminated
  E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expir