Edge E1455-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884521713192), received between May 8, 2017 and May 14, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (18 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 6'' BOVIE TIP CAUGHT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 25173710 ↗
• MalfunctionFeb 15, 2026Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ELECTRODE BROKE AND THE PATIENT EXPERIENCED A 1ST DEGREE BURN. PHOTO PROVIDED SHOWED THAT THE ELECTRODE'S INSULATION WAS DAMAGE AND THE COMPONENT DISENGAGED. THE USER EXPLORED ALL OTHER OPTIONS THAT COULD HAVE HAPPENED AND DETERMINED THAT IT WAS DUE TO THE ELECTRODE BREAKING.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24341653 ↗
• MalfunctionJan 21, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LEFT THORACOSCOPIC WEDGE RESECTION, LEFT THORACOSCOPY COMPLETION LINGULA BISEGMENTECTOMY AND A LEFT THORACOSCOPIC MEDIASTINAL AND HILAR LYMPHADENECTOMY. AFTER REMOVING THE NECESSARY LYMPH NODES, THE SURGEON WAS PULLING THE SCOPE OUT WHEN SHE NOTICED THAT APPROXIMATELY A 4MM SECTION OF THE LEFT LUNG TISSUE HAD BURNED. THE SURGERY WAS PAUSED WHILE THE DEVICE WAS INSPECTED AND FOUND TO HAVE A SMALL BURN THROUGH THE INSULATION APPROXIMATELY AN INCH FROM THE TIP. THE DEVICE WAS REMOVED FROM THE FIELD, A NEW ONE WAS USED AND THE SURGERY WAS COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 24128153 ↗
• InjuryDec 19, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LAPAROTOMY, WHEN THE PENCIL WAS REMOVED FROM THE PATIENT, PLASTIC SHEATH ON THE INSULATED FIRST ELECTRODE WAS MISSING. THE PROCEDURE WAS DELAYED BECAUSE THEATER STAFF WERE TRYING TO LOCATE PLASTIC SHEATH. THE SECOND ELECTRODE'S INSULATION ON DIATHERMY TIP CAME OFF AND COULD NOT BE RETRIEVED FROM THE ABDOMEN. XRAY WAS NOT PERFORMED BECAUSE THE CLEAR PLASTIC PIECE ON THE INSULATED ELECTRODES WAS NOT RADIO OPAQUE AND CANNOT DE DETECTED. PATIENT WAS CLOSED WITHOUT BEING ABLE TO LOCATE THE PIECE OF PLASTIC. ADDITIONAL TWO ELECTRODES FROM PHOTO OBSERVATION SHOWING IT WAS NOT USED YET WITH CLAIM FROM REPORTER THAT IT WAS EASILY MANIPULATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23848291 ↗
• InjuryAug 5, 2025Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS A HOLE IN THE INSULATION THAT THEY STATED WAS NOT THERE WHEN PROCEDURE STARTED. THIS CAUSED A 2ND DEGREE BURN AND THE SURGEON HAD TO RESECT ADDITIONAL TISSUE TO ENSURE APPROXIMATION OF HEALTHY TISSUE UPON CLOSURE OF THE INCISION. THE FACILITY USED A NON-MEDTRONIC PATIENT RETURN ELECTRODE.

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

  MAUDE report 22716917 ↗
• MalfunctionJun 20, 2025Fire; Fire

  IT WAS REPORTED THAT THE DEVICE HAD A SPONTANEOUS FLAME ON THE END OF THE BOVIE TIP.

  Patient problems: Insufficient Information

  MAUDE report 22297349 ↗
• MalfunctionJun 10, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SPINE PROCEDURE, THE PLASTIC PART OF THE TIP DETACHED AT THE TIME OF ELECTRODE USAGE. A PIECE FELL INTO THE PATIENT'S CAVITY AND WAS REMOVED IMMEDIATELY BY FORCEPS AND RETRIEVED. THERE WAS NO X-RAY PERFORMED, AND NO ADDITIONAL MEDICAL PROCEDURE WAS NEEDED. ANOTHER ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175844 ↗
• MalfunctionJun 27, 2024Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST RECONSTRUCTION WITH EXCHANGE OF TISSUE EXPANDERS FOR GEL IMPLANTS, PATIENT EXPERIENCED A BURN IN AN AREA NOT BEING CAUTERIZED. THE BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SUPERFICIAL 2ND DEGREE BURN TREATED WITH TOPICAL OINTMENT. BACTRIACIN ZINC-POLYMYXIN B (POLYSPORIN) AND ANTIMICROBIAL WATER RESISTANT BANDAGE (MEPILEX) AND SURGICAL BRA WAS ALSO PLACED PER USUAL PROCEDURE. CUT/COAG SETTINGS WERE 30/30. CUSTOMER ALSO REPORTED THAT THE REMOVAL OF THE ELECTRODE HAS BEEN QUITE DIFFICULT. CUSTOMER EXCHANGED ELECTRODES OFTEN THROUGHOUT THE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19626052 ↗
• MalfunctionJun 21, 2024Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST PROPHYLACTIC MASTECTOMY SKIN SPARING AND BILATERAL BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND BIOLOGIC MESH FOR SOFT TISSUE SUPPORT, DEVICE HAD ARCING/SPARKING ISSUE AND THE REMOVAL OF THE ELECTRODE HAS BEEN QUIET DIFFICULT. SURGEON EXCHANGE ELECTRODES OFTEN THROUGHOUT THE PROCEDURE. PATIENT EXPERIENCED A BURN ALONG THE INCISION DURING CAUTERY USE. THE BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SURGEON NOTED BOVIE WAS NOT USED IN THAT AREA. AREA OF SKIN WAS REMOVED PER USUAL PROCEDURE NOT BECAUSE OF BURN. CUT/COAG SETTINGS WERE 40/40.

  Patient problems: Burn(s)

  MAUDE report 19589220 ↗
• MalfunctionJun 21, 2024Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST RECONSTRUCTION WITH EXCHANGE OF TISSUE EXPANDERS FOR GEL IMPLANTS, THE DEVICE HAD ARCING/SPARKING. THE STAFF REPORTED THAT WHEN THEY CHANGED OUT THE ELECTRODE FOR THE INSULATED TIP, THE ELECTRODE WAS EXTREMELY (AND UNUSUALLY) DIFFICULT TO REMOVE FROM BOVIE PENCIL. REMOVAL OF THE ELECTRODE HAS BEEN QUITE DIFFICULT. EXCHANGED ELECTRODES OFTEN TH ROUGHOUT THE PROCEDURE. THIS CAUSED PATIENT TO EXPERIENCE A BURN IN AN AREA NOT BEING CAUTERIZED. BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SUPERFICIAL 2ND DEGREE BURN ON THE LEFT BREAST TREATED WITH TOPICAL OINTMENT. CUT/COAG SETTINGS WERE 40/40. BACITRACIN ZINC-POLYMYXIN B (POLYSPORIN) AND ANTIMICROBIAL WATER RESISTANT BANDAGE (MEPILEX) AND SURGICAL BRA ALSO PLACED PER USUAL PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19584628 ↗
• MalfunctionFeb 6, 2024Overheating of Device; Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TONSILLECTOMY, THE DEVICE MELTED, AND THE COATING CAME OFF AND CAUSED EXTENDED HEATING AROUND THE ELECTRODE THAT CAME INTO CONTACT THAT CAUSED BURN ON PATIENT¿S INTERIOR CHEEK.

  Patient problems: Burn(s)

  MAUDE report 18652817 ↗
• MalfunctionNov 20, 2023Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A MASTECTOMY, THE INSULATION ON THE BLADE ELECTRODE PEELED OFF, 3 HOLES FORMED ON THE SIDE EXPOSING THE METAL. THIS CAUSED A BURN ON THE PATIENT'S SKIN (APPROXIMATELY 2 INCHES). NO PIECE FELL INTO THE PATIENT'S CAVITY. ANOTHER ELECTRODE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18175517 ↗
• MalfunctionJun 30, 2023Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING RADICAL NEPHRECTOMY, THE DOCTOR CLAIMS THERE WAS AN INSULATION ISSUE WHILE USING THE BOVIE PENCIL WHICH CAUSED AN ARC THAT BURNED THE PATIENTS BOWEL, WAS CORRECTED LATER IN PROCEDURE. ANOTHER SURGEON CAME INTO PROCEDURE AND FIXED THE BURN. NO DIRECT ISSUE WITH GENERATOR, ITS PART OF MONOPOLAR CIRCUIT.

  Patient problems: Burn(s)

  MAUDE report 17238635 ↗
• MalfunctionMay 23, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A FLAME OBSERVED WHEN ACTIVATING ELECTRODE ON METAL FORCEPS. THE FIRE PRODUCED WAS ESTIMATED TO BE 2 CM. THERE WAS NO OPERATING ROOM FIRE. IT WAS EXTINGUISHED WHEN PENCIL STOPPED ACTIVATING AND MOVED AWAY FROM METAL FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987375 ↗
• MalfunctionFeb 2, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BOVIE TIP CREATED A FLAME WHEN TOUCHED BY INSULATED FORCEPS. THE FLAME WENT OUT IMMEDIATELY, NO HARM TO PATIENT. THE FLAME WAS THE SIZE OF A CANDLE FLAME. IT SELF-EXTINGUISHED. THERE WAS NO OR FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16288195 ↗
• MalfunctionJan 11, 2023Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE INSULATED AREA BECAME EXPOSED AND THE PATIENT HAD A BURN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 16138309 ↗
• MalfunctionDec 1, 2022Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE MELTED AND FELL APART, INSULATED PORTION OF ELECTRODE WEAKENED/TORE RESULTING IN ENERGY CONCENTRATING AND INSULATION BEING FURTHER DAMAGED. DEVICE WAS REMOVED FROM CAUTERY PENCIL AND REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15897575 ↗
• MalfunctionNov 1, 2022Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT MELTED. THERE WAS 1ST DEGREE BURN INJURY.

  Patient problems: Burn(s)

  MAUDE report 15710335 ↗
• MalfunctionAug 23, 2022Peeled/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 PROCEDURE, WHEN TRYING TO REMOVE ELECTRODE FROM THE PENCIL THEY WERE USING A CLAMP. IN DOING SO THE SHEATH WAS CRACKED. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280075 ↗
• InjuryJul 6, 2021Melted; Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Melted; Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, THE DEVICE MELTED. A DEEP PARTIAL THICKNESS BURN WAS NOTED BY THE ASSISTING NURSE ON THE PATIENT'S RIGHT CHEST WALL MEASURING 1 X 1.5CM. UPON INSPECTION, A DEFECT ON THE INSULATION ON THE SHAFT OF THE DIATHERMY TIP WAS NOTICED. THE SKIN WAS CAUTERIZED BY THE LEAKED CURRENT THROUGH THE INSULATION DEFECT. THE BURN AREA WAS SURGICALLY EXCISED AND THE WOUND CLOSED.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 12125757 ↗
• MalfunctionOct 27, 2020Peeled/Delaminated; Arcing; Peeled/Delaminated; Arcing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PENCIL WAS BEING USED WITH THE ELECTRODE. UPON ACTIVATION, SCRUB TECH OBSERVED A SPARK AND NOTICED A SMALL BREAK IN INSULATION ON SHAFT OF ELECTRODE. SMALL FAINT MARK LEFT ON PATIENT'S SKIN. NO BLISTER OR DAMAGE TO SKIN REPORTED. NOTHING FELL INTO THE PATIENT'S CAVITY AND NO ADDITIONAL TREATMENT NECESSARY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10740930 ↗
• MalfunctionDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING REPLACEMENT OF BREAST IMPLANTS, THE DEVICE WAS CAUSE A MINOR BURN TO THE PATIENT. THEY PADDED THE WOUND WITH COLD SALINE. DRESSING AT END OF PROCEDURE WITH BACITRACIN OINTMENT AND XEROFORM GAUZE. THEY CHANGE THE DEVICE TO A LIKE DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 9529780 ↗
• InjuryNov 5, 2019Component Missing; Adverse Event Without Identified Device or Use Problem; Component Missing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY CASE, THE PATIENT HAD BURN ALONG INCISION OR SUBCUTANEOUS TISSUE. BURN SITE WAS SURGICALLY EXCISED. AND SMALL AREA OF DEVICE'S BLUE COATING WAS MISSING ABOUT 1 INCH FROM BASE OF INSERTION POINT. NOTHING FELL INTO PATIENT'S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 9282978 ↗
• MalfunctionOct 31, 2019Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THERE WAS A HOLE IN THE BLUE INSULATION.

  Patient problems: No Information

  MAUDE report 9261931 ↗
• MalfunctionSep 16, 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 PROCEDURE, THE DEVICE HAD A CRACKED INSULATION. THE PATIENT PRESENTED WITH 3 1ST DEGREE BURN OF 1MM SIZE AROUND THE BREAST AREA THAT WAS TREATED WITH ANTIBIOTIC OINTMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9071684 ↗