Edge E1465Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521713222), received between Aug 30, 2017 and May 24, 2026 — classified as 2 injuries, 18 malfunctions.

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

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLEAR INSULATED BOVIE TIP SHEATH HAS FALLEN OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267264 ↗
• MalfunctionMay 19, 2026Peeled/Delaminated; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLEAR INSULATED BOVIE TIP SHEATH HAS FALLEN OFF.

  Patient problems: Insufficient Information

  MAUDE report 25218042 ↗
• MalfunctionFeb 9, 2026Melted; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS USING THE DEVICES ON A PATIENT IN THE OR, THE TIP MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290530 ↗
• MalfunctionFeb 9, 2026Melted; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS USING THE DEVICES ON A PATIENT IN THE OPERATING ROOM, THE TIP MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290500 ↗
• MalfunctionFeb 9, 2026Melted; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS USING THE DEVICES ON A PATIENT IN THE OR, THE TIP MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290456 ↗
• MalfunctionFeb 9, 2026Melted; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS USING THE DEVICES ON A PATIENT IN THE OR, THE TIP MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290407 ↗
• MalfunctionApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL SAGITTAL SPLIT OSTEOTOMY AND GENIOPLASTY, HARVEST BONE ASPIRATE RIGHT ILIAC CREST, THE CAUTERY TIP WAS BENT TO 90 DEGREES IN USE TO MARK CUTTING GUIDE ON MANDIBLE, WHILE IN USE WHERE CAUTERY WAS BENT AT 90 DEGREES PLASTIC COATING STILL REMAINED INTACT BUT HAD BURNT PATIENT'S UPPER LEFT LIP. BURN APPEARED TO BE 1ST DEGREE AND ESTIMATED COUPLE MILLIMETERS IN DIAMETER. ANTIBIOTIC OINTMENT APPLIED POST-OPERATIVE. PROLONGED CARE WAS NECESSARY LIKE ASSESSING THE SITE THAT WAS BURNT AND PROVIDING THE TREATMENT OF ANTIBIOTIC OINTMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21842156 ↗
• MalfunctionMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EXCISION OF BASAL CELL CARCINOMA LESION ON THE RIGHT TEMPLE AREA OF THE PATIENT, THE PATIENT SUFFERED SUPERFICIAL BURNS DUE TO A FIRE. WHEN THE PATIENT WAS PLACED ON THE OPERATING TABLE, THE PATIENT RECEIVED LOW FLOW OXYGEN BY VENTIMASK. THE SURGEON INJECTED LIDOCAINE TO INCISION LINE. SURGEON USED CAUTERY TO BEGIN EXCISION OF SKIN CANCER. AFTER USING THE CAUTERY FOR THE INITIAL INCISION, A FIRE BROKE OUT IN THE VICINITY OF THE DRAPE AND VENTIMASK. IMMEDIATELY THE VENTIMASK WAS REMOVED AND THE OXYGEN WAS SHUT OFF. THE FIRE WAS QUICKLY EXTINGUISHED. ALL EQUIPMENT THAT WAS USED WERE REMOVED. SURGERY CONTINUED WITH NEW BOVIE, DRAPE AND INSTRUMENTATION. THE LESION OF CONCERN WAS REMOVED AND SENT FOR FROZEN SECTION UNTIL ALL MARGINS WERE CLEAR. BACITRACIN OINTMENT WAS APPLIED TO THE FACIAL BURN. THE PATIENT WAS DISCHARGED TO HOME IN GOOD CONDITION WITH PRESCRIPTIONS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21710337 ↗
• MalfunctionMar 18, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING USE, THE PATIENT WAS PREPPED FOR SURGERY ON THEIR MAXILLA BY BRUSHING THEIR TEETH WITH CHLOROHEXIDINE MOUTH WASH AND BETADINE PREP ON THEIR FACE. ON THE FIRST CUT WITH CAUTERY, THE SURGEON NOTICED A SPARK, INCLUDING AN EMBER ON THE DRAPE. THERE WAS NO APPARENT BURN TO THE PATIENT ON EXAMINATION AND NO COMPROMISE OF THE STERILE FIELD. THE CAUTERY PEN, TIP AND MACHINE WERE ALL CHANGED OUT AND THE INITIAL SET ISOLATED.

  Patient problems: Insufficient Information

  MAUDE report 21635031 ↗
• MalfunctionNov 27, 2023Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PENCIL WAS NOTICED TO HAVE MELTED PRIOR TO TOUCHING THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212020 ↗
• MalfunctionFeb 22, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE DEVICE AS NOT INSULATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416626 ↗
• MalfunctionMay 7, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN WAS USING ELECTRICAL CAUTERY WHEN THE BOVIE TIP STARTED GLOWING BRIGHTLY AND APPEARED TO BE ON FIRE. THE PHYSICIAN STOPPED USING IT AND NOTICED THE BOVIE TIP APPEARED MELTED. THE BOVIE PENCIL WAS REMOVED AND A NEW ONE WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791256 ↗
• MalfunctionApr 14, 2021Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, DURING EXPLORATORY LAPAROTOMY, DIAGNOSTIC THORACOSCOPY WITH THORACOSCOPIC LYSIS OF ADHESION, REPAIR OF RECURRENT CONGENITAL DIAPHRAGMATIC HERNIA REPAIR WITH MESH, PLACEMENT OF CHEST TUBE, REPAIR OF ENTEROTOMY AND GASTROCUTANEOUS FISTULA TAKE DOWN, ABDOMINAL WASH OUT, THE SURGEON WAS USING ELECTRICAL CAUTERY DURING SURGERY WHEN THE BOVIE TIP STARTED GLOWING BRIGHTLY AND APPEARED TO BE ON FIRE BUT THERE WAS NO OPERATING ROOM FIRE. THE SURGEON IMMEDIATELY STOPPED USING THE CAUTERY AND NOTICED THE NEEDLE BOVIE TIP APPEARED TO HAVE MELTED. THE TIP WAS REMOVED FROM THE PENCIL WITH FORCEPS AFTER THE GENERATOR HAD BEEN UNPLUGGED AND DROPPED INTO A METAL BASIN AND A NEW BOVIE PENCIL AND TIP WERE OPENED TO THE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662629 ↗
• MalfunctionApr 13, 2021Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, DURING EXPLORATORY LAPAROTOMY, DIAGNOSTIC THORACOSCOPY WITH THORACOSCOPIC LYSIS OF ADHESION, REPAIR OF RECURRENT CONGENITAL DIAPHRAGMATIC HERNIA REPAIR WITH MESH, PLACEMENT OF CHEST TUBE, REPAIR OF ENTEROTOMY AND GASTROCUTANEOUS FISTULA TAKE DOWN, ABDOMINAL WASH OUT, THE SURGEON WAS USING ELECTRICAL CAUTERY DURING SURGERY WHEN THE BOVIE TIP STARTED GLOWING BRIGHTLY AND APPEARED TO BE ON FIRE BUT THERE WAS NO OPERATING ROOM FIRE. THE SURGEON IMMEDIATELY STOPPED USING THE CAUTERY AND NOTICED THE NEEDLE BOVIE TIP APPEARED TO HAVE MELTED. THE TIP WAS REMOVED FROM THE PENCIL WITH FORCEPS AFTER THE GENERATOR HAD BEEN UNPLUGGED AND DROPPED INTO A METAL BASIN AND A NEW BOVIE PENCIL AND TIP WERE OPENED TO THE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657664 ↗
• MalfunctionApr 12, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD FLAME OR FIRE ISSUE. THIS WAS A VATS/EXP LAP CASE. THE SURGEON WAS OPERATING IN THE THORACIC CAVITY AT TIME OF THE EVENT. THE TIP OF THE ELECTRODE CAUGHT ON FIRE WHEN ACTIVATED "LIT UP LIKE A CANDLE" WAS THE DESCRIPTION FROM STAFF. THE SURGEON PULLED THE DEVICE AWAY FROM PATIENT AND NO KNOWN INJURY RESULTED. GENERATOR SETTINGS WERE 20/20 AND IT WAS NOT KNOWN IF CUT OR COAG WAS ACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648898 ↗
• MalfunctionApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICES CAUSED 2ND DEGREE BURN ON BOTH CORNERS OF THE MOUTH, ONE ON THE OUTSIDE AND THE OTHER WAS INSIDE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9986788 ↗
• MalfunctionDec 30, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING A TONSILLECTOMY, THEY WERE USING A PENCIL WITH THE NEEDLE ELECTRODE (PLUGGED INTO AN FT10). IT WAS WORKING AS EXPECTED UNTIL THE NURSE PLUGGED IN THE SMOKE TUBING TO THE SMOKE EVAC (THE SMOKE EVACUATOR WAS AN IC MEDICAL PRODUCT). AT THIS POINT THE ELECTRODE BURST INTO FLAME. THE COMPROMISED INSULATION ON THE ELECTRODE HAPPENED AFTER THE FACT; WHEN THEY WERE REMOVING THE ELECTRODE FROM THE PENCIL. THERE WAS NO REPORTED ISSUE WITH THE PENCIL; DAMAGE WAS ONLY ON THE ELECTRODE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530770 ↗
• MalfunctionMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE METAL INSIDE OF ELECTRODE BURNT THROUGH THE SLEEVE CAUSING THE METAL TO BE EXPOSED DURING SURGERY, THUS BURNING THE PATIENT IN THE PROCESS.

  Patient problems: Burn(s)

  MAUDE report 8632434 ↗
• InjuryMar 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SHOULDER REPLACEMENT PROCEDURE, THE DEVICE NEEDLE BROKE WHILE APPLYING AROUND MUSCLE JOINT AND FELL OFF INTO PATIENTS CAVITY. X RAY WAS PERFORMED BUT THEY WERE NOT ABLE TO FIND ANYTHING. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 8405556 ↗
• InjuryAug 30, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A BREAST AUGMENTATION PROCEDURE, A 5X2.5MM PATIENT BURN OCCURRED ON THE OUTER EDGE OF THE LEFT NIPPLE, ON THE LATERAL MOST PORTION OF AN INCISION MADE WITH THE DEVICE. INSPECTION OF THE DEVICE DURING THE PROCEDURE FOUND TWO SMALL AREAS OUTSIDE OF THE NEEDLE WERE MISSING INSULATION. A NEW NEEDLE TIP WAS USED TO CONTINUE THE PROCEDURE. THE SURGEON DEBRIDED AND REPAIRED THE BURNED AREA. NO INSULATION WAS RETRIEVED, AND THE ISSUE WAS NOTICED MID-PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 6832168 ↗