Megadyne 0016AMRecalls & reported problems
Megadyne Medical Products, Inc. · E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, Modified Extended Insulation, 4 inch (10.2 cm) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559100219), received between Jul 9, 2024 and Jun 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Human-Device Interface Problem1
- Material Integrity Problem1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS AN ISSUE WITH ONE OF THE MEGADYNE BOVIE TIPS DURING SURGERY. THE BOVIE TIP IS REPORTED TO OF CHIPPED DURING SURGERY WHILE IN USE ON THE PATIENT. THE BOVIE TIP SAVED FOR EXAMINATION. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210373 ↗InjuryJul 9, 2024Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING A TONSILLECTOMY THAT A DEFECT IN THE PRODUCT CAUSED PATIENT BURN. BURN WILL REQUIRE TREATMENT AND FOLLOW UP.
Patient problems: Burn(s)
MAUDE report 19701669 ↗
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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