Megadyne ME7251ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559105665), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.

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, K141587); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Arcing of Electrodes; Appropriate Device Problem Term/Code Not Available; Arcing of Electrodes; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE MALE TO FEMALE GENDER CONFIRMATION SURGERY, THE DOCTOR EXPERIENCED A MALFUNCTION WITH THE DEVICE. TWO MINUTES IN CASE HE WAS USING COAG AND THE TIP TURNED RED HOT AND BEGAN TO MELT. HE HAD BEEN USING THE FLAT PART OF THE BLADE AND THE ARCHING COMING FROM THE EDGES AND THE DEVICE LIT UP AND MELTED. THERE WAS SOME RETAINED PRODUCT IN THE PATIENT, BUT HE WAS ABLE TO REMOVE THE BOVI TIP FROM THE DEVICE AND REPLACE IT WITH A 0012 TIP WHICH HE USED TO REMOVE THE RETAINED PRODUCT FROM THE PATIENT AND FINISHED HE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081791, K141587. 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