Megadyne 0695Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559101254), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 malfunction.

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

• MalfunctionApr 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAP HIATAL HERNIA PROCEDURE, THAT THE BLACK INSULATION ON SHAFT WAS PEELING OFF THE SHAFT. THIS REUSABLE SHAFT WAS RECENTLY PURCHASED AND USED ONCE OR TWICE. THIS WAS DISCOVERED WHEN PEEL PACK WAS OPENED AND NOT USED IN PROCEDURE. SPD IN FACILITY FOLLOWED IFU STERILIZATION AND CLEANING RECOMMENDATIONS. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713214 ↗

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