Megadyne 0013Recalls & reported problems
Megadyne Medical Products, Inc. · E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, 2.75 inch (7 cm) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559100127), received between Apr 11, 2024 and Apr 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Arcing of Electrodes1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2024Arcing of Electrodes; Activation, Positioning or Separation Problem; Arcing of Electrodes; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING A PLASTIC SURGERY THE MEGADYNE ELECTRODE IS USED IN THE DISSECTION OF A FLAP, AND IT BEGINS TO CARBONIZE UPON CONTACT WITH THE TISSUE, IT IS CLEANED AND THE TISSUE CONTINUES TO ADHERE TO THE ELECTRODE, GENERATING AN INCREASE IN THE TEMPERATURE OF THE TISSUE AND A FLAME EFFECT BETWEEN THE ELECTRODE AND THE TISSUE. IT WAS DECIDED TO CHANGE THE ELECTRODE FOR OTHER REF AND IT IMPROVES. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088434 ↗
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 · TerminatedE-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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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