MEGADYNE 2255JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559104644), received between Jul 1, 2021 and Feb 2, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN TESTING IT WAS FOUND THAT THE RF SENSOR CAUSES THE UNIT TO RUN CONTINUOUSLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282839 ↗
• MalfunctionMay 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLACK PLASTIC PART FOR CORD WAS DETACHED AND THE INSIDE EXPOSED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496852 ↗
• MalfunctionAug 13, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ACCOUNT TURNED ON THE MESE1 WITH RF SENSOR CONNECTED, AND THE SMOKE EVACUATION CANNOT BE ACTIVATED (EVEN WITH CONNECTING CABLE CONNECTED OR MANUAL BUTTON PRESSED). THEN THEY TURNED ON THE MESE1 WITH RF SENSOR DISCONNECTED, THE SMOKE EVACUATION CAN BE ACTIVATED WITH MANUAL BUTTON OR CONNECTING CABLE. FINALLY THEY TURNED ON THE MESE1 WITHOUT CONNECTING RF SENSOR, ONCE PLUGGED IN RF SENSOR, EVACUATION ACTIVATE CONTINUOUSLY WITHOUT CONNECTING DIATHERMY OR PRESSING MANUAL BUTTON. AFTER REBOOT, BECAME THE FIRST ISSUE. THE ABOVE ISSUES ARE TESTING WITHOUT CONNECTING TO ANY DIATHERMY OR ENERGY DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317800 ↗
• MalfunctionJul 1, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SMOKE EVACUATOR ACTIVATED WHEN THE RF SENSOR WAS CONNECTED. THERE WAS NO PROBLEM TO THE HARMONIC DEVICE WHEN THE RF SENSOR WAS NOT CONNECTED. GEN04 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100316 ↗