Edge E1450-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521713123), received between Apr 20, 2017 and Jul 9, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fire” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026

  THE PROVIDER WAS USING A COVIDIEN BLADE ELECTRODE 4" BOVIE DURING A CASE, AND DURING THE USE OF THE BOVIE, THE TIP CAUGHT FIRE, WITH A SMALL FLAME APPEARING. THE PROVIDER NOTICED IMMEDIATELY, AND WAVED THE BOVIE IN THE AIR AND THE FLAME WAS QUICKLY EXTINGUISHED. THE BOVIE WAS UNPLUGGED AND PUT TO THE SIDE, AND ANOTHER PLUGGED IN AND USED WITHOUT ISSUE FOR THE REMAINDER OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769438 ↗
• MalfunctionJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HOSPITAL'S SPINE SURGEON REPORTED AN INCIDENT IN WHICH A NON-MEDTRONIC SMOKE EVACUATION MONOPOLAR HANDPIECE, WHICH HAD BEEN PLACED ON THE PATIENT'S CHEST ON THE BACK AND THE SURGEON LEANED ON THE MONOPOLAR HANDPIECE AND IT ACCIDENTALLY ACTIVATED, CAUSING A BURN TO THE SURGEON'S HAND DURING THE FINAL STAGES OF SURGERY AND CAUSED A FIRST DEGREE BURN TO THE SURGEON'S HAND. THE SURGEON HAD FELT AN ELECTRIC SHOCK, PAIN, AND HEARD A BUZZING SOUND. THE SURGEON HAD PULLED HIS HAND AWAY FROM THE INCIDENT, CAUSING THE HANDPIECE TO FLY TO THE FLOOR. TWO 2-3 MM BURN SPOTS WERE FOUND ON THE SKIN OF THE SURGEON'S ARM. THERE WAS NO TREATMENT DONE TO THE BURN. NOW, FOUR DAYS AFTER THE INCIDENT, THE SURGEON IS DOING WELL AND THE BURN HAS NOT REQUIRED ANY SIGNIFICANT TREATMENT. THE MONOPOLAR INSTRUMENT HAD BEEN USED THROUGHOUT THE SURGERY AND HAD FUNCTIONED WITHOUT ANY PROBLEMS. THE PATIENT DID NOT SUFFER ANY EFFECTS FROM THE INCIDENT. THE HANDPIECE WAS CONNECTED TO A GENERATOR AT THE TIME OF THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Electric Shock; Pain

  MAUDE report 21124031 ↗
• MalfunctionNov 14, 2024Fire; Fire

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD IGNITED WHILE IT WAS USED ON TISSUE BUT THERE WAS NO IMPACT ON THE PATIENT OR SURROUNDING EQUIPMENT. AN INTERVIEW WAS CONDUCTED, BUT THE SPECIFIC USAGE SITUATION (SUCH AS PROXIMITY TO STAPLE OR HIGH OXYGEN CONCENTRATION ETC.) WAS UNCLEAR. A NEW ELECTRODE WAS BROUGHT IN AGAIN, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683935 ↗
• MalfunctionNov 7, 2024Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BOVIE SHEATH MELTED AND CRACKED. SHEATH WAS STILL ON AND NOTHING FELL ON PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631483 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE USING THE ELECTRIC SCALPEL, IT WAS NOTICED THAT PART OF THE ELECTRODE TIP WAS CHIPPED (NORMAL BEFORE USE). ELECTRIC SCALPEL GENERATOR SETTINGS FOR CUTTING WERE 100W AND FOR COAGULATION WAS 70W. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916335 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE USING THE ELECTRIC SCALPEL, IT WAS NOTICED THAT PART OF THE ELECTRODE TIP WAS CHIPPED (NORMAL BEFORE USE). ELECTRIC SCALPEL GENERATOR SETTINGS FOR CUTTING WERE 100W AND FOR COAGULATION WAS 70W. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915757 ↗
• MalfunctionSep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A PAD FROM THE "KITPACK CARDIAC PACK" CAUGHT FIRE WHEN IT CAME INTO CONTACT WITH THE NON-ACTIVE ELECTRIC SCALPEL, IN MONOPOLAR MODE UU (USAGE UNIQUE) PLATE (SINGLE USE PRODUCT) REUSED DUE TO THE REFERENCE BEING OUT OF STOCK. THE PATIENT WAS NOT BURNED, AS THE COMPRESS WAS IMMEDIATELY REMOVED FROM THE OPERATING FIELD, HOSPITAL STAY WAS NOT CHANGED. THE SCRUB NURSE THREW WATER ON THE TABLE TO EXTINGUISH THE FIRE. THE MEDICAL DEVICE PRESENT ON THE FIELD WERE DESTERILIZED (DROPPED). TOOK A NEW MONOPOLAR PENCIL. PROCEDURE WAS COMPLETED NORMALLY AFTER PRODUCTS CHANGED WITH MEDTRONIC PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17766835 ↗
• MalfunctionSep 27, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING AN OPEN UROLOGICAL SURGERY, THE EDGE COATING ON THE TIP OF THE DEVICE WAS PEELED OFF. THE PIECE DID NOT FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491034 ↗
• MalfunctionAug 2, 2021Fire; Melted; Peeled/Delaminated; Fire; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING BREAST REDUCTION SURGERY, THE EDGE COATED BLADE OF THE SEP6015 CAUGHT FIRE. THE MELTED INSULATION DID NOT FALL APART AND DID NOT FALL INTO PATIENT'S CAVITY; IT SEEMED TO DISAPPEAR/VAPORIZE. NO PHYSICAL PARTS CAME OFF OF THE BLADE. THE BLADE LOOKED WHITE THE FACT THAT THE COATING CAUGHT FIRE. THIS HAPPENED WORKING WITH THE PURE CUT MODE AT 50 WATTS IN THE BREAST FATTY TISSUE. THE FLAME WAS NOT BIG AND WENT OUT PRETTY SOON. IT STARTED DURING NORMAL USE OF ELECTROSURGERY IN THE MENTIONED SETTINGS AND ENDED AFTER WAITING FOR A SMALL INSTANT AND WAVING THE PENCIL THAT CAUSED THE SMALL FLAME TO GO OUT. NO FURTHER ACTION WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258931 ↗
• MalfunctionAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN HYSTERECTOMY, THE ELECTRODE SPARKS BURNT AT SURGEON¿S FINGER. THERE WAS 1ST DEGREE BURN AND TREATED BY PAIN KILLER. THEY USED ANOTHER ELECTRODE TO COMPLETE THE PROCEDURE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10467540 ↗
• MalfunctionJun 26, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A FIRE INITIATED AT TIP OF BLADE ELECTRODE. EXTINGUISHED RAPIDLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737897 ↗
• MalfunctionOct 5, 2017Fire; Fire

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, A FLAME OCCURRED WHEN THE ELECTRODE TIP CAME INTO CONTACT WITH TISSUE AND WAS ACTIVATED. NO PATIENT INJURY RESULTED FROM THE ISSUE, AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916465 ↗
• MalfunctionMay 22, 2017Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT A PATIENT LESION OCCURRED AWAY FROM THE OPERATIVE AREA FOLLOWING AN ELECTRICAL ARC FROM THE ELECTRODE DURING A WHIPPLE PROCEDURE. THE INSULATION WAS REPORTED TO HAVE A HOLE IN THE PROXIMAL PART OF THE ELECTRODE. THE INJURY WAS DESCRIBED AS A 1ST DEGREE REDDENED AREA. NO MEDICAL INTERVENTION WAS REQUIRED. THE INCIDENT PENCIL WAS DISCARDED BY THE CUSTOMER. AN ERBE GENERATOR WAS IN USE AT FORCE 60, EFFECT 4, COAG MODE. THE SERIAL NUMBER IS UNKNOWN. MEDTRONICS INITIAL INVESTIGATION FOUND THE INSULATION ON THE SHAFT OF THE ELECTRODE WAS DAMAGED EXPOSING METAL. THE DEVICE FILED HIPOT TESTING.

  Patient problems: Burn(s)

  MAUDE report 6581405 ↗
• MalfunctionApr 20, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE EDGE COATING ON ONE SIDE OF THE BLADE PEELED OFF AS THE SCRUB TECH ATTEMPTED TO REMOVE ESCHAR BUILDUP WITH A RAYTEC. THE BLADE WAS THEN REMOVED AND A NEW E1450-4 BLADE WAS USED TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508737 ↗