Megadyne 004010JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559105122), received between Jun 4, 2019 and Jun 4, 2019 — classified as 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K072559); 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.

• MalfunctionJun 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE PROTECTIVE COATING ON PRODUCT DID NOT PROTECT PATIENT TONGUE. THE PATIENT TONGUE WAS BURNED. THE PROCEDURE WAS AND WAS 15 MINS IN LENGTH. THE PATIENT WAS IN THE SUPINE POSITION. NO PREP SOLUTION OR ANTISEPTICS/CLEANSERS WERE USED. THE GENERATOR SETTINGS WERE CUT 35 AND COAG 35. THIS WAS USED WITH COVIDIEN VALLEYLAB FT10. THERE WAS NO FUNCTIONAL ISSUES NOTED WITH THE DEVICE DURING THE CASE. THE SETTINGS WERE NOT INCREASED. THE PATIENT CALL THE NEXT DAY. THE SURGEON DISCOVERED A 5 MM 2ND DEGREE BURN ON THE LEFT SIDE OF THE MOUTH. THE SKIN LESION REPORT STATES THE PATIENT'S SKIN CONDITION AT THE LESION SITE BEFORE THE PROCEDURE WAS BLISTERED AND CRUSTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8668888 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072559. One submission often covers many models, so check the product and lot details in each record.

• Z-2257-2023 · Jun 15, 2023 · Open, Classified
  MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch
• Z-1151-2014 · Feb 27, 2014 · Terminated
  Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device i