Megadyne 0118ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10614559101414), received between Jan 4, 2017 and Jun 1, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A T&A PROCEDURE THE COATING AROUND THE TIP BURNS OFF. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037425 ↗
• MalfunctionMay 17, 2023Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE COATING AROUND THE TIP BURNS OFF. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944958 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE ATTACHED MEDWATCH MW5112003.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 15758945 ↗
• MalfunctionNov 5, 2019Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A BROW LIFT, THE DOCTOR WAS USING THE MEGADYNE E-Z TIP WITH A MEGADYNE MEGAPOWER GENERATOR FOR THIRTY MINUTES THEN THE TIP TURNED INTO A GLOWING BALL AND THE INSULATION BUBBLED UP ON IT, WHILE ACTIVATING. A SECOND LIKE E-Z TIP FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281824 ↗
• InjuryJan 4, 2017Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  PER CUSTOMER: THE SURGEON NOTICED THAT TISSUE NEXT TO THE INSULATED PART OF THE SURGICAL TIP WAS BEING AFFECTED BY THE DIATHERMY, IMMEDIATELY UPON OPERATING. TISSUE NEXT TO THE INSULATED PORTION OF THE MEGAFINE TIP WAS DAMAGED DUR TO WHAT APPEARED TO BE CURRENT "LEAKING" THROUGH THE INSULATION. THE SURGEON WAS REQUIRED TO MAKE AN ADDITIONAL SUTURE, LEAVING THE PATIENT WITH AN ADDITIONAL SCAR.

  Patient problems: Burn(s)

  MAUDE report 6223238 ↗

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