Megadyne 0118Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559101278), received between Sep 12, 2018 and Jul 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (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.

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.

• MalfunctionJul 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN PREPARING THE SUPPLIES FOR PERSONAL PHARMACY SURGERY, IT IS NOTICED THAT DEVICE TIP HAS ITS SECONDARY PACKAGING DEFECTIVE LOSING THE STERILIZATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700480 ↗
• MalfunctionFeb 28, 2023Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN OPEN LAPAROTOMY THE BOVIE PENCIL TIP CAUGHT ON FIRE. A NEW PENCIL WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454422 ↗
• MalfunctionJul 23, 2019Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING A SPINAL CORD TUMOUR A PIECE OF DIATHERMY NEEDLE POINT INSULATION BECAME DETACHED DURING SURGICAL PROCEDURE. IT WAS NOTED BY THE SURGEON WHEN A PIECE FELL OFF INTO THE STERILE FIELD DURING THE PROCEDURE. DEVICE HAD BEEN IN USE FOR APPROXIMATELY 30MIN. DIATHERMY SCABBARD WAS IN USE. THERE WERE NO KNOCKS OR OTHER TRAUMA OF THE PRODUCT NOTED PRIOR TO THE ISSUE. NO SCRATCH PAD WAS IN USE. REUSABLE MONOPOLAR DIATHERMY PENCIL WAS IN USE AT THE TIME. ITEMS WAS RETRIEVED, CHECKED FOR COMPLETENESS. NO KNOWN HARM OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8819724 ↗
• MalfunctionSep 12, 2018Fire; Melted; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISKECTOMY, COLLAGED TIP LOOKED LIKE A BIRTHDAY CANDLE. IT LOOKED LIKE THE TIP HAD MELTED A BIT, THERE WAS A LOT OF TISSUE ON IT, AND THAT IS WHAT CAUSED THE LITTLE FLAME. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871686 ↗

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