Megadyne 1400JJRecalls & reported problems
Megadyne Medical Products, Inc. · Mega Power Monopolar Foot Pedal, Foot Switch, 12ft, for use with Mega Power generator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10614559105269), received between Feb 20, 2019 and Nov 6, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Self-Activation or Keying” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Self-Activation or Keying3
- Activation, Positioning or Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2023Self-Activation or Keying; Activation, Positioning or Separation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING A LAP GASTRIC SLEEVE PROCEDURE WHERE THE DOCTOR REPORTS THAT HE TRIES TO COAGULATE AND WHEN PRESSING THE COAGULATION BUTTON ON THE MONOPOLAR PEDAL THIS ACTIVATED THE CUT MODE THEREFORE, THE DOCTOR PREFERRED NOT TO CONTINUE USING OUR MEGADYNE CONSOLE AND CHANGE IT TO A VALEYLLAB CONSOLE. THE SURGERY WAS NOT DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18072887 ↗MalfunctionAug 29, 2023Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FOOTSWITCH IS STILL ACTIVATING WHEN NOT PRESSED. CUSTOMER TO ORDER REPLACEMENT FOOTSWITCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17644463 ↗MalfunctionFeb 20, 2019Self-Activation or Keying
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD FIRE EVEN WHEN THE FOOT CONTROL WAS NOT PUSHED. CASE COMPLETED WITH ANOTHER FOOT PEDAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8356017 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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