Megadyne 0016MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559100226), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN URETER REPAIR THAT AN INTRAOPERATIVE BURN WAS REPORTED DUE TO APPARENT INSULATION FAILURE. THE CUSTOMER STATED THAT DAMAGE TO THE INSULATION WAS BELIEVED TO HAVE HAPPENED DURING THE PROCEDURE. OTHER DISPOSABLE ELECTRODES IN THE SAME LOT SHOW INTACT AND UNMANAGED INSULATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19971916 ↗

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