Edge E1450-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521713130), received between Oct 27, 2017 and Jan 7, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fire” (8 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.

• MalfunctionJan 7, 2026Fire

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE DEVICE¿S TIP IGNITED (MATCH-SIZED FLAME) DURING USE. THE FLAME SELF-EXTINGUISHED AFTER ACTIVATION WAS STOPPED. NO OPERATING ROOM FIRE WAS REPORTED. FOLLOWING THE INITIAL INCIDENT, THE BIOMED DEPARTMENT CONDUCTED TESTING ON THE ESU AND IDENTIFIED HIGH-VOLTAGE ISSUES WITH THE GENERATOR. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990536 ↗
• MalfunctionJun 10, 2023Failure to Deliver Energy; Melted; Peeled/Delaminated; Failure to Deliver Energy; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD NO COAGULATION AND HAD MELTED. THEY WONDER WHY THE PLASTIC WAS MELTED WHETHER THERE WAS A CRACK BEFORE SURGERY OR THE UNIT'S COAGULATION POWER SETTING WAS FAILED. PHOTO WAS SUBMITTED SHOWING A DAMAGED INSULATION. PATIENT HAD BLEEDING BUT BLOOD TRANSFUSION WAS NOT NEEDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17101960 ↗
• MalfunctionFeb 16, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP PROCEDURE, THE PENCIL WITH ELECTRODE IGNITED WITH A SMALL FLAME, OUTSIDE OF THE PATIENT. THE FIRE WENT OUT ON IT¿S OWN, STAFF SAID THERE WAS A LOT OF FAT ON THE ELECTRODE, AND THE ELECTRODE IGNITED WHEN IT WAS NOT ACTIVATED. THE ELECTRODE HAS SOME BLACK ESCHAR ON THE COATING, BUT DID NOT FEEL LIKE THE COATING WAS BROKEN. GENERATOR SETTINGS WERE 60/60, 60 COAG WAS BEING USED. BIOMED CHECKED OUT THE GENERATOR AND DID NOT THINK ITS A GENERATOR ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386837 ↗
• MalfunctionMay 21, 2019Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BREAST ENLARGEMENT PROCEDURE, THE DEVICE HAD A MALFUNCTION AND CAUSED A ONE-MILIMETER FIRST DEGREE BURN TO THE PATIENT. EXCISION WAS DONE TO TREAT THE BURNED PART. IT WAS NOTED THAT THE SHEATH OF THE SHAFT OF THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH PRECAUTION WITH THE USE OF THE SAME DEVICE.

  Patient problems: Burn(s)

  MAUDE report 8628534 ↗
• MalfunctionMar 13, 2019Material Fragmentation; Peeled/Delaminated; Failure to Cut; Material Fragmentation; Peeled/Delaminated; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS UNABLE TO CUT SKIN WITH PENCIL. WHEN SWITCHED THE LONG TIP, IT WAS NOTICED THAT SOME OF THE COATING FLAKED OFF INTO THE PATIENT'S CAVITY, BUT FULLY RETRIEVED. THERE WAS NO PATIENT INJURY. AFTER THE PROCEDURE, THE SAME GENERATOR USED ON ANOTHER CASE AND IT WORKED FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418245 ↗
• MalfunctionJan 31, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING A THORACIC CASE, THE CONSULTANT ASKED HIS ASSISTANT TO USE THE DIATHERMY MACHINE (SETTING 50) WITH THE MEDIUM TIP (WITH RUBBER SHOD) TO TOUCH THE FORCEPS WITH IT. THERE WAS A FLAME ON THE DIATHERMY TIP AND HAD TO DROP IT ON THE FLOOR AND WAS STEPPED ON. A NEW DIATHERMY PENCIL WITH MEDIUM TIP (WITH RUBBER SHOD) WAS PROVIDED AND THE SETTING ON THE DIATHERMY MACHINE WAS CHANGED DOWN TO 20. DIATHERMY MACHINE WAS CHECKED; THERE WERE NO ISSUES AND IN SERVICE DATE, AND SETTINGS USED COMPARABLE TO OTHER CARDIAC CENTRES. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293436 ↗
• MalfunctionJan 30, 2019Fire; Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING USE THE BIOBURDEN ON THE TIP STARTED TO BURN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8291478 ↗
• MalfunctionNov 19, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN THE ELECTRODE WAS ACTIVATED, THE TIP PRODUCED A MATCH SIZE FLAME. THIS FLAME ONLY OCCURRED WHEN THE DEVICE WAS ACTIVATED, SO IT WAS SELF EXTINGUISHED. GENERATOR WAS USED DURING THE EVENT. REPLACED WITH SIMILAR DEVICE AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085513 ↗
• MalfunctionOct 18, 2018Fire; Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS A FIRE COMING FROM THE ELECTRODE TIP DURING COAGULATION OF TISSUE IN FULGURATE MODE AT 45 SETTING ON THE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979222 ↗
• MalfunctionOct 16, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING A THORACIC PROCEDURE, THEY USED THE DIATHERMY PENCIL AND IT WAS SET TO 50 WITH THE MEDIUM TIP AND RUBBER SHOD TO TOUCH THE FORCEPS WITH IT. THEY THEN NOTICED THAT THE DIATHERMY PENCIL HAS A FLAME ON ITS TIP AND IT WAS DROPPED ON THE FLOOR. THEY STEPPED ON THE DIATHERMY PENCIL TIP THAT WAS ON THE FLOOR AND THEY USED A NEW DIATHERMY PENCIL WITH NEW MEDIUM TIP AND RUBBER SHOD AND THE SETTING WAS CHANGED DOWN TO 20 TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969006 ↗
• MalfunctionFeb 13, 2018Fire; Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE¿S ELECTRODE CAUGHT FIRE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267369 ↗
• MalfunctionOct 27, 2017Peeled/Delaminated; Flare or Flash; Peeled/Delaminated; Flare or Flash

  THE CUSTOMER REPORTED THAT BURN MARKS OCCURRED ON THE PATIENT SKIN DURING A BREAST AUGMENTATION PROCEDURE. EXAMINATION OF THE DEVICE DURING THE PROCEDURE FOUND HOLES IN THE BLUE INSULATION. THE DEVICE WAS IN USE WITH A VALLEYLAB FORCEFX GENERATOR AT THE SETTINGS OF 40W SPRAY. A SECOND EDGE BLADE ELECTRODE WAS USED WITH THE SAME GENERATOR/ACCESSORIES AND NO FURTHER ISSUES OCCURRED.

  Patient problems: Burn(s)

  MAUDE report 6985977 ↗