Megadyne 004125Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10614559105146), received between Nov 29, 2018 and Dec 31, 2020 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K072559); 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 18, 2026.

Recalls naming this device

1. Jun 15, 2023Class IIOpen, Classified

   An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

   Z-2257-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Failure to Fire

  COAGULATER WOULD NOT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11100340 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A TONSILECTOMY AND ADENOIDECTOMY ON A PATIENT AND, AFTER THE PROCEDURE WAS COMPLETED, NOTICED A SECOND DEGREE BURN WITH BLISTERS TO THE RIGHT CORNER OF THE PATIENT'S MOUTH, ON BOTH THE LIP AND MOUTH. THE PATIENT WAS TREATED WITH BACITRACIN OINTMENT AND RELEASED.

  Patient problems: Partial thickness (Second Degree) Burn; Tissue Damage

  MAUDE report 9264015 ↗
• MalfunctionDec 10, 2018Device Remains Activated

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ALL DEVICES WERE DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148694 ↗
• MalfunctionDec 10, 2018Self-Activation or Keying

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148638 ↗
• MalfunctionDec 10, 2018Device Remains Activated

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148601 ↗
• MalfunctionDec 10, 2018Self-Activation or Keying

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148573 ↗
• MalfunctionDec 10, 2018Device Remains Activated

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148565 ↗
• MalfunctionDec 10, 2018Device Remains Activated

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148546 ↗
• MalfunctionDec 10, 2018Device Remains Activated

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148544 ↗
• MalfunctionDec 10, 2018Device Remains Activated

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148515 ↗
• MalfunctionDec 10, 2018Self-Activation or Keying

  IT WAS REPORTED THAT DURING A NASAL PROCEDURE, THE BUTTONS ON THE HAND HELD SUCTION COAGULATOR WOULD CONTINUE TO ACTIVATE THE DEVICE, AFTER THE DOCTOR RELEASED THE BUTTON THE DEVICE. THE DOCTOR USED FOOTSWITCH ACTIVATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148380 ↗
• MalfunctionNov 29, 2018Failure to Shut Off

  IT WAS REPORTED THAT DURING A TONSILS ADENOIDS, THE SURGEON WAS USING A SUCTION COLAGATOR AND THEY WERE ON A FOOT PEDAL, HE WAS REMOVING THE DEVICE FROM THE PATIENT AND ENDING UP BURNING THE PATIENT ON THE LIP. SMALL ELECTROCAUTERY BURN (4X4MM) ON THE RIGHT SUPERIOR LIP BORDER NEAR ORAL COMMISSURE. WHEN THE SURGEON RELEASED HIS FOOT FROM THE PETAL, THE ENERGY DID NOT STOP TO THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118201 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072559. One submission often covers many models, so check the product and lot details in each record.

• Z-1151-2014 · Feb 27, 2014 · Terminated
  Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device i