Megadyne 0690SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559101247), received between Oct 22, 2019 and Jun 25, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE IS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065694 ↗
• MalfunctionOct 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER CLEANING THE DEVICE THE PLASTIC COATING CAME OFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221827 ↗

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