Edge E1455-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521713185), received between Jul 3, 2017 and Aug 20, 2026 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50336074 ↗
• MalfunctionAug 11, 2026Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  Patient problems: Superficial (First Degree) Burn; Tissue Breakdown

  MAUDE report 50205127 ↗
• MalfunctionApr 28, 2026Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE CAUGHT FIRE. THE FIRE WAS THE SIZE OF A MATCH FLAME AND IT WAS EXTINGUISHED BY PUTTING THE DEVICE INTO STERILE WATER. THERE WAS NO OPERATING ROOM FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011399 ↗
• MalfunctionJul 14, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE TIP HAD ARCED AND BURNED THE PATIENT. BURN WAS THIRD DEGREE AND APPROXIMATELY 5CMX4MM LOCATED IN THE INFRAMAMMARY FOLD. THE SURGEON WAS ABLE TO CUT THE BURN OUT. THE ONLY DELAY CAUSED BY THE ADVERSE EVENT, WAS CUTTING THE BURN OUT OF THE SKIN AND NO OTHER TREATMENT DONE.

  Patient problems: Full thickness (Third Degree) Burn; Unspecified Tissue Injury

  MAUDE report 22493345 ↗
• InjuryJul 11, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CAUTERIZING END MELTED THE BLUE COVER ALLOWING THE CLEAR COVER TO FALL OFF AND INTO THE PATIENT WHICH IS DIFFICULT TO LOCATE AND REMOVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22476769 ↗
• MalfunctionMay 29, 2025Peeled/Delaminated; Arcing; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, THE ELECTRODE DEVELOPED A HOLE THAT CAUSED ELECTRICITY TO ESCAPE, DAMAGING THE TISSUE AND RESULTING IN A 2ND AND 3RD DEGREE BURN WITH SIZE OF 3 X 1,5 CM. SPARKS WERE NOTED AND STOPPED USING THE DEVICE TO EXTINGUISHED IT BUT THERE WAS NO OPERATING ROOM FIRE.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 22107098 ↗
• MalfunctionOct 30, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE ELECTRODE'S COVER ON THE TIP GOT DETACHED. THE DETACHED PIECE DID NOT FELL INTO THE PATIENT CAVITY. ANOTHER ONE WAS TAKEN OUT AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575324 ↗
• MalfunctionAug 26, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING EXTENSIVE TOTAL HYSTERECTOMY PROCEDURE, THE TRANSPARENT TUBE (INSULATOR) IN FRONT OF THE DEVICE'S ELECTRODE PART FELL OFF. IT WAS COLLECTED, BUT IT WAS DISPOSED OF WITH THE ELECTRODE. NO PIECE FELL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20067281 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE INSULATION FELL OFF INTO PATIENTS CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993677 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS USED INSIDE THE PATIENT AND THE PLASTIC INSULATION HAD BROKEN OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498473 ↗
• MalfunctionNov 29, 2023

  WHEN THE PHYSICIAN WENT TO USE THE BOVIE TIP INSIDE THE PATIENT HE NOTICED THAT THE PLASTIC INSULATION HAD BROKEN OFF INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18239411 ↗
• MalfunctionNov 14, 2023Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING INSERTION OF PAIN STIM PACEMAKER, THE UNIT'S INSULATED TIP SHOWED TO HAVE MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133596 ↗
• MalfunctionAug 4, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A FLAME WAS GENERATED FROM THE ELECTRODE TIP. IT WAS REPLACED WITH A NEW E1455-4 AND WAS USED, THEN THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466979 ↗
• MalfunctionDec 30, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE COATING PART OF THE SHAFT WAS PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097066 ↗
• MalfunctionOct 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST AUGMENTATION WITH PROSTHETIC IMPLANTS, WHEN USING THE DEVICE WHEN EXTENDED TIP IN A SMALL INCISION LEFT BREAST, THE SKIN EDGED WAS BURNED. THE BURNED AREA WAS EXCISED. THERE WAS A BLACK MARK IN THE INSULATION AT THE SITE OF IMPAIRED INTEGRITY OF THE INSULATION. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 10767452 ↗
• MalfunctionOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING MASTECTOMY PROCEDURE, THE ELECTRICAL CURRENT OF THE DEVICE HAVE BURNED THROUGH THE BLADE INSTEAD COMPLETELY DOWN TO THE PENCIL. THUS RESULTING TO A 1ST DEGREE BURN (REDNESS) ON THE PATIENT'S SKIN BUT IT WAS THE PART OF THE SKIN THAT WAS GOING TO BE REMOVED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10697110 ↗
• MalfunctionOct 6, 2020Thermal Decomposition of Device

  WHEN USING THE 4" INSULATED BOVIE WITH THE EXTENDED TIP, IN A SMALL INCISION LEFT BREAST, THE SKIN EDGE WAS BURNED. THERE WAS A BLACK MARK ON THE INSULATION AT THE SITE OF IMPAIRED INTEGRITY OF THE INSULATION.

  Patient problems: Burn, Thermal

  MAUDE report 10634554 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSULATED BOVIE ARCHED AT THE DISTAL END OF THE ELECTRODE SHAFT, OPENING THE BLUE INSULATION AND ARCHING ENERGY BURNED THE LATERAL EDGE OF THE SKIN ON THE PATIENT'S BREAST. THEY WERE ABLE TO EXCISE THE EDGE OF THE TISSUE AND CLOSED WITHOUT NOTICEABLE DAMAGE.

  Patient problems: Burn(s)

  MAUDE report 10483314 ↗
• MalfunctionAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, THE INSULATION WAS DAMAGED AND FELL APART WHEN TRYING TO REMOVE THE ELECTRODE FROM THE CAUTERY PENCIL USING A HEMOSTAT INSTRUMENT BECAUSE THE ELECTRODE WAS DIFFICULT TO REMOVE FROM THE PENCIL. ENERGY LEAKED THROUGH THE DAMAGED INSULATION AREA OF THE ELECTRODE AND CAUSED A BURN ON SKIN TISSUE. THE EVENT WAS ATTRIBUTED TO DAMAGING THE INSULATION BY USING THE HEMOSTAT INSTRUMENT FOR REMOVAL, AND THE SKIN TISSUE THAT WAS BURNED WAS FORTUNATELY ALREADY AN AREA THAT WAS PLANNED TO BE EXCISED DURING THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 10400868 ↗
• InjuryMar 31, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL NEEDLE LOCALISATION BIOPSY AND CENTRAL NODE BIOPSY, THE PATIENT HAD A 6CM AWAY FROM THE SURGICAL SITE A FULL THICKNESS 3RD DEGREE BURN REQUIRING TO BE EXCISED. THE SURGEON EXCISED THE BURN SITE AND SUTURED IT. THE SURGEON DESCRIBED THAT THERE WAS A HOLE IN ELECTRODE BODY DUE TO SCRUB NURSE CHANGING ELECTRODE TIP WITH ARTERY. A PHOTO SUBMITTED SHOWING THE LONG ELECTRODE BLUE INSULATION HAS SMALL HOLE IN THE MIDDLE OF ITS LENGTH.

  Patient problems: Full thickness (Third Degree) Burn; No Code Available

  MAUDE report 9902237 ↗
• MalfunctionAug 27, 2019Arcing; Noise, Audible

  WHILE USING THE BOVIE WITH AN INSULATED 4" ELECTRODE BLADE IN THE INCISION, WORKING WITH THE BOVIE TIP INTO THE LATERAL SIDE OF THE BREAST, SURGEON HEARD A POP SOUND AND NOTED 3 AREAS AT THE EDGE AND UNDER THE LEFT BREAST INCISION WHERE TISSUE HAD BEEN BURNED DURING CAUTERIZATION IN INCISION. UPON EXAMINATION OF 4" BOVIE TIP A BLACK CIRCULAR MARK WAS NOTED WITHIN THE INSULATED COATING POSSIBLY HAVING CAUSED AN ARC DURING CAUTERIZATION. BOVIE SETTING WERE 35 CUT PURE AND 35 COAG FULGURATE. IT WAS CONFIRMED THE BOVIE PAD WAS SECURELY ON THE PATIENT.

  Patient problems: Burn, Thermal

  MAUDE report 8935020 ↗
• InjuryAug 12, 2019Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE SURGEON FINISHED THE RIGHT BREAST AND HAD TRANSITIONED TO BEGIN WORKING ON THE LEFT BREAST. UPON MAKING THE INCISION LINE, THERE WAS AN ARC BETWEEN THE TIP OF THE BOVIE AND THE INSULATED SLEEVE, WHICH RESULTED IN 3 SMALL BURNS ALONG THE INCISION LINE. THEY PULLED THE AFFECTED ELECTRODE OUT OF THE BOVIE PENCIL, GRABBED A BRAND NEW ELECTRODE AND INSERTED IT INTO THE BOVIE PENCIL AND PROCEEDED. THE SURGEON EXCISED THE BURN IN AN ELLIPTICAL AREA ABOUT 5CM LONG AND 2CM WIDE WHICH TAPERED AT EACH END TO AESTHETICALLY COMPLETE THE PROCEDURE. THIS HAD ADDED LESS THAN 30 MINUTES TO THE PROCEDURE. THE 3 SEPARATE SKIN BURNS OCCURRED AFTER THE SURGEON HEARD A LITTLE "POP". SIZE OF BURNS PER SURGEON: 5X5MM, 7X7MM, 8X8MM. DOCTOR SAID ONE BURN WAS ON THE AREOLA (5X5MM), AND THE OTHER TWO WERE BELOW THE INCISION. INSULATION ON THE ELECTRODE HAS A BURN/HOLE IN IT (PICTURE PROVIDED). THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Burn(s); No Code Available; Tissue Damage

  MAUDE report 8882073 ↗
• MalfunctionMar 26, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, THE SURGEON WAS USING A PENCIL WITH THE EXTENDED 4 INCH GUARDED TIPS. IMMEDIATELY AFTER USING IT INSIDE THE WOUND, WHILE THE SURGEON HAD THE TIP ABOVE THE WOUND, IT IGNITED A FLAME. THEY IMMEDIATELY CHANGED THE HAND PIECE AND MACHINE. THEY ALSO SWITCHED THE GENERATOR AND OPENED NEW PAD AND PENCIL TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT BURNED, THE SURGEON WAS NOT BURNED. THERE WAS NO FURTHER INFORMATION AVAILABLE AND GOOD FAITH ATTEMPTS HAVE BEEN MADE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452515 ↗
• MalfunctionFeb 7, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE LUMPECTOMY, AN ELECTRODE BECAME LOOSE AND FELL OUT OF THE PENCIL. IT FELL INTO THE PATIENT CAVITY BUT WAS RETRIEVED BY HAND. ANOTHER ELECTRODE WAS OPENED AND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316874 ↗
• MalfunctionNov 29, 2018Fire; Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THEY USED THE PENCIL THE GAUZE IGNITED. THERE WAS A PRESENCE OF FLAME, BUT DISAPPEARED IMMEDIATELY. BOTH OF THE DEVICE WAS CHANGE TO CONTINUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8114750 ↗