Megadyne 0855CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559104019), received between Feb 7, 2019 and Mar 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A COLOSTOMY TAKE DOWN PROCEDURE THAT A DRY SPONGE CAUGHT ON FIRE AFTER ENERGY FROM THE TIP OF THE PENCIL "ARC'D" TOWARDS THE SPONGE DURING A PROCEDURE INVOLVING A MEGEN1 AND TELESCOPING SMOKE PENCIL (10 FT). THE DRY SPONGE WAS REPORTEDLY 2 INCHES AWAY FROM THE TIP OF THE PENCIL WHILE ACTIVATING. THE BRAND OF SMOKE EVACUATOR WAS NOT REPORTED ON THE CALL. THE CUSTOMER SENT THE MEGEN1 TO BIOMED FOR TROUBLESHOOTING BUT THEY THREW AWAY THE GROUNDING PAD AND TELESCOPING PENCIL. NO PATIENT CONSEQUENCE OR PROCEDURE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719253 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A SECOND-DEGREE PATIENT BURN OCCURRED. FOLLOWING THE PROCEDURE, A SECOND-DEGREE BURN WAS LOCATED AT THE SITE OF THE DISPOSABLE PATIENT RETURN ELECTRODE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8318585 ↗