Megadyne C117MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559103326), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081791); 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.

• InjuryJan 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OPEN CHEST/ ABDOMEN FOR LATERAL LYMPH NODE DISSECTION, SALPINGO-OOPHORECTOMY, AND HYSTERECTOMY, IT WAS FOUND THAT THE TIP WAS DEFORMED DURING SURGERY. AT THE DOCTOR'S DISCRETION, EXTENSIVE CLEANING AND CHECKING WITH A C-ARM, NO MISSING PARTS WERE FOUND, BUT THE WOUND WAS CLOSED AS IS. THE SURGEON HAD NO MEMORY OF HITTING IT OR ANY INTERFERENCE FROM METAL. THE OPINION IN THE OPERATING ROOM WAS THAT IT MAY HAVE MELTED. THE BURNT PARTS HAVE SOLIDIFIED AND IT LOOKED TO BE MISSING, BUT THE MISSING PART HAS NOT BEEN FOUND WHEN THE DEVICE WAS CHECKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223776 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081791. 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