Megadyne 0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559100141), received between May 3, 2021 and Dec 1, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IT WAS NOTICED THAT ONE OF THE ITEMS IN THEIR ORDER IS PACKAGED INCORRECTLY. THE OUTER WHITE PRODUCT BOX READS 0014 BUT THE PRODUCT INSIDE THE BOX READS 0014A. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248660 ↗
• InjuryJul 27, 2023Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A BILATERAL AUGMENTATION MAMMOPLASTY, DUAL PLANE, WITH RELEASE OF THE INFERIOR BREAST TISSUE PROCEDURE A LONG BOVIE TIP WAS OPENED ONTO THE SURGICAL FIELD. UPON START OF THE SURGERY, THE BOVIE MACHINE WAS SET TO CUT: 40 AND COAG: 40. THE PATIENT WAS BURNED ON THE RIGHT BREAST INCISION AND THE BOVIE TIP SEEMED TO HAVE BURNED AWAY PART OF THE OUTER COATING OF THE BOVIE TIP. THE USE OF THIS TIP WAS IMMEDIATELY DISCONTINUED, AND DR. STATED HE HAD TO CHANGE THE SURGERY DUE TO THE BURN. A NEW BOVIE TIP WAS OPENED FOR USE BUT WAS PASSED OFF DUE TO THE POTENTIAL OF ANOTHER BURN. PER DR.'S OPERATIVE REPORT: ¿OF NOTE, THE LONG INSULATED BOVIE TIP USED FOR THE DISSECTION IN THE POCKETS WAS DISCOVERED TO HAVE A HOLE IN THE INSULATION. THIS RESULTED IN SKIN BURNS ON THE INFERIOR PORTION OF THE INCISION ON THE RIGHT BREAST. THE BURNED SKIN WAS ABLE TO BE EXCISED AND THE INCISION CLOSED WITHOUT INCIDENT.¿

  Patient problems: Burn(s)

  MAUDE report 17405587 ↗
• InjuryJul 26, 2023Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LONG BOVIE TIP WAS OPENED ONTO THE SURGICAL FIELD. UPON START OF THE SURGERY, THE BOVIE MACHINE WAS SET TO CUT: 40 AND COAG: 40. THE PATIENT WAS BURNED ON THE RIGHT BREAST INCISION AND THE BOVIE TIP SEEMED TO HAVE BURNED AWAY PART OF THE OUTER COATING OF THE BOVIE TIP. THE USE OF THIS TIP WAS IMMEDIATELY DISCONTINUED, AND DR. STATED HE HAD TO CHANGE THE SURGERY DUE TO THE BURN. A NEW BOVIE TIP WAS OPENED FOR USE BUT WAS PASSED OFF DUE TO THE POTENTIAL OF ANOTHER BURN. PER DR.'S OPERATIVE REPORT: ¿OF NOTE, THE LONG INSULATED BOVIE TIP USED FOR THE DISSECTION IN THE POCKETS WAS DISCOVERED TO HAVE A HOLE IN THE INSULATION. THIS RESULTED IN SKIN BURNS ON THE INFERIOR PORTION OF THE INCISION ON THE RIGHT BREAST. THE BURNED SKIN WAS ABLE TO BE EXCISED AND THE INCISION CLOSED WITHOUT INCIDENT.¿.

  Patient problems: Burn(s)

  MAUDE report 17398012 ↗
• MalfunctionMay 3, 2021No Audible Alarm; Break

  DURING THE SURGICAL PROCEDURE, IT WAS NOTED THAT THE PATIENT'S SKIN HAD SEVERAL BURN MARKS AROUND THE INCISION SITE. DOCTOR INSPECTED THE BOVIE TIP, WHICH HAD A BREAK IN THE INSULATION. NO ALARM SOUND WAS NOTED OR HEARD FROM THE VALLEY LAB UNIT. THE BOVIE TIP WAS ISOLATED REMOVED AND REPLACED. THE INCIDENT WAS REPORTED TO THE CHARGE NURSE AND THE BOVIE TIP WAS HANDED TO HER.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 11759685 ↗

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