Megadyne 0600MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559101063), received between Feb 3, 2021 and Feb 3, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K943055); 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.

• InjuryFeb 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT HAD LAPAROSCOPIC SURGERY ON (B)(6) 2020. PATIENT WAS DISCHARGED. ON (B)(6) 2021 THE PATIENT PRESENTED IN THE ER WITH ABDOMINAL PAIN. DURING A CT SCAN, IT WAS DISCOVERED THAT RETAINED PRODUCT WAS IDENTIFIED. SURGERY WAS PERFORMED AND THE PRODUCT WAS EXTRACTED. THE CASE WAS DELAYED BY NINETY MINUTES.

  Patient problems: Abdominal Pain

  MAUDE report 11273256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K943055. One submission often covers many models, so check the product and lot details in each record.

• Z-0469-03 · Dec 20, 2002 · Terminated
  Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
• Z-0468-03 · Dec 20, 2002 · Terminated
  Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE