Edge E1450XRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521713154), received between Oct 1, 2018 and May 16, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fire” (5 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 16, 2026.

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.

• MalfunctionMay 16, 2025Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING A BELOW KNEE AMPUTATION PROCEDURE, THE TIP "LIT UP LIKE A CANDLE". TIP WAS REPLACED AND THE PENCIL WORKED FINE. LATER THE SAME CASE, ANOTHER PENCIL WAS USED AND THE TIP SPARKED AND "BURNED LIKE CANDLE" AGAIN. THEY USED NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO OPERATING ROOM FIRE AND IT EXTINGUISHED ON ITS OWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035886 ↗
• MalfunctionMay 16, 2025Fire; Fire

  ACCORDING TO THE REPORTER, DURING A BELOW KNEE AMPUTATION PROCEDURE, THE TIP "LIT UP LIKE A CANDLE". TIP WAS REPLACED AND THE PENCIL WORKED FINE. LATER THE SAME CASE, ANOTHER PENCIL WAS USED AND THE TIP SPARKED AND "BURNED LIKE CANDLE" AGAIN. THEY USED NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO OPERATING ROOM FIRE AND IT EXTINGUISHED ON ITS OWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035480 ↗
• MalfunctionApr 28, 2025Melted; Overheating of Device; Peeled/Delaminated; Melted; Overheating of Device; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CAUTERY'S TIPS WERE VISIBLY MELTED/CHARRED FROM APPARENT EXTREME HEAT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919667 ↗
• MalfunctionApr 28, 2025Melted; Overheating of Device; Peeled/Delaminated; Melted; Overheating of Device; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CAUTERY'S TIPS WERE VISIBLY MELTED/CHARRED FROM APPARENT EXTREME HEAT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919593 ↗
• MalfunctionApr 28, 2025Melted; Overheating of Device; Peeled/Delaminated; Melted; Overheating of Device; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CAUTERY'S TIPS WERE VISIBLY MELTED/CHARRED FROM APPARENT EXTREME HEAT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919457 ↗
• MalfunctionApr 28, 2025Melted; Overheating of Device; Peeled/Delaminated; Melted; Overheating of Device; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE CAUTERY'S TIPS WERE VISIBLY MELTED/CHARRED FROM APPARENT EXTREME HEAT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919405 ↗
• MalfunctionJan 2, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ILEAL RESECTION, WHILE OPERATING INSIDE THE ABDOMINAL CAVITY WITH A SMALL INCISION FOR ADHESION DISSECTION, A BLUE FRAGMENT WAS SEEN INSIDE THE ABDOMINAL CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432299 ↗
• MalfunctionMay 1, 2023Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING A REVISION KNEE PROCEDURE, THE DEVICE WAS USED SEVERAL TIMES AND WHILE IN THE KNEE, IT STARTED TO SPARK. IT WAS WITHDRAWN FROM THE KNEE AND THE DEVICE WAS IMMEDIATELY CAUGHT ON A SMALL FIRE/FLAME BUT IT WENT OUT ON ITS OWN. THE FIRE OCCURRED AT THE END OF THE BOVIE TIP AND WAS AWAY FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845060 ↗
• MalfunctionFeb 16, 2023Fire; Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, A SURGICAL FIRE IGNITED ON THE TIP OF THE ELECTRODE WITH THE SIZE OF SMALL MATCH STICK. THE ELECTRODE WAS THE ONE THAT COMES IN THE PENCIL. IT WAS EXTINGUISHED BY ITS OWN. THE STAFF KEPT THE PENCIL AND THE GENERATOR, CHANGED THE ELECTRODE AND CONTINUED THE PROCEDURE WITHOUT ANY OTHER INSTANCES OCCURRING. THERE LOOKS LIKE THERE IS WHITE ON THE ELECTRODE, ON BOTH SIDES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386531 ↗
• MalfunctionMar 16, 2021Melted; Adverse Event Without Identified Device or Use Problem; Melted; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING FREON LAPAROSCOPIC, THE PROCEDURE WAS CONVERTED TO OPEN BUT NOT DUE TO THE ELECTRODE THAT LOOKED CHARRED AT TIP. THEY OPENED A NEW ELECTRODE TO COMPLETE PROCEDURE. THE PHOTO ATTACHED SHOWED THAT THE ELECTRODE TIP WAS MELTED.

  Patient problems: Insufficient Information

  MAUDE report 11494829 ↗
• MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BURNING AT THE ELECTRODE REGION WAS SEVERE, SO THE PHYSICIAN HAD AN IMPRESSION THAT THE TIP WAS MISSING AND THE NURSE REQUESTED AN INVESTIGATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284991 ↗
• MalfunctionOct 1, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHILE USING THE DEVICE THE TIP OF IT STARTED ON FIRE. THE SURGEON IMMEDIATELY STOPPED USING THE DEVICE AND THE FIRE WENT OUT. THE FIRE DID NOT AFFECT PATIENT TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922814 ↗