Megadyne 0009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10614559100042), received between Aug 9, 2018 and Jun 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PRODUCT PACKING IS DAMAGED. THE PACKAGING PAPER IS PEELED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518491 ↗
• MalfunctionApr 7, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PROBLEM WAS DETECTED AFTER SURGERY, PART OF INSULATION MISSING AND COULD NOT BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626942 ↗
• MalfunctionAug 9, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PART OF THE BLUE COATING (NEAR TO THE BALL ELECTRODE) WAS BROKEN IN THE CASE OF COLPOSCOPY. X-RAY WAS TO BE PERFORMED FOR FINDING OUT THE BROKEN PART. PATIENT IMPACT UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770148 ↗

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