Edge E1455Recalls & reported problems

Summary

The FDA's MAUDE database contains 238 adverse event reports that list this exact device (DI 10884521713178), received between Apr 21, 2017 and Sep 16, 2026 — classified as 20 injuries, 218 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (149 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 238 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Entrapment of Device

  It was reported that during a procedure, the device's tip was tearing the patient's skin. Another insulated tip was opened worked effectively.

  Patient problems: Skin Tears

  MAUDE report 50786689 ↗
• MalfunctionSep 16, 2026Entrapment of Device

  It was reported that during a procedure, the device's tip was tearing the patient's skin. Another insulated tip was opened worked effectively.

  Patient problems: Skin Tears

  MAUDE report 50786568 ↗
• MalfunctionSep 16, 2026Entrapment of Device

  It was reported that during a procedure, the device's tip was tearing the patient's skin. Another insulated tip was opened worked effectively.

  Patient problems: Skin Tears

  MAUDE report 50786454 ↗
• MalfunctionSep 10, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714422 ↗
• MalfunctionJul 30, 2026Peeled/Delaminated; Detachment of Device or Device Component; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50091254 ↗
• MalfunctionJun 16, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE THE TRANSPARENT PLASTIC OF THE DEVICE CAME LOOSE FROM THE COAGULATION TIP AND ENDED UP IN THE PATIENT. THE SURGEONS (2) IMMEDIATELY NOTICED THIS PART AND REMOVED IT. THE SMALL, TRANSPARENT TUBULAR PLASTIC SHEATH DOES NOT HOLD ANOTHER SMALL SHEATH AS TRANSPARENT, WHICH EASILY DETACHES FROM THE INSTRUMENT AND FALLS OFF. NO X-RAY WAS REQUIRED TO ASSIST IN LOCATION THE PIECE. NO SIGNIFICANT EXTENSION OF THE DURATION OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514886 ↗
• MalfunctionJun 4, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST CASE, THE SURGEON REGULARLY REMOVED AND REINSERTED THE BOVIE TIP TO CLEAR THE SUCTION COMPONENT OF THE COMBINATION SUCTION/CAUTERY DEVICE. THIS REPEATED REMOVAL AND REINSERTION WAS ROUTINE AND NECESSARY, AND THE SAME BOVIE TIP WAS REUSED THROUGHOUT THE CASE. IN THAT INSTANCE, THE SURGEON OBSERVED A SMALL AREA OF SKIN BURNING AT A TIME WHEN THE TIP WAS BELIEVED TO BE WELL BEYOND THE SKIN INCISION AND SHOULD NOT HAVE CAUSED AN INJURY. UPON INSPECTION, THE SURGEON NOTED HOLES IN THE INSULATION NEAR THE BASE OF THE BOVIE TIP, SUGGESTING THAT THE NORMALLY INSULATED PORTION MAY HAVE CONTACTED THE SKIN WHILE THE ACTIVE TIP WAS DEEPER IN THE INCISION.

  Patient problems: Burn(s)

  MAUDE report 25392037 ↗
• MalfunctionMay 1, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE HEART TRANSPLANT PROCEDURE, THE NON-REMOVABLE PLASTIC SLEEVE ON THE INSULATED CAUTERY TIP WAS DETACHED FROM BLUE INSERT AND FELL ONTO THE STERILE FIELD AND NOT INTO THE PATIENT. IT WAS FOUND BY THE SCRUB NURSE APPROXIMATELY 20 MINUTES AFTER NOTICING THE MISSING PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054361 ↗
• MalfunctionApr 7, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLEAR INSULATION OF THE ELECTRODE FELL INTO THE PATIENT'S CAVITY/BODY. IT WAS FULLY RETRIEVED BUT X-RAY WAS NOT REQUIRED TO ASSIST IN LOCATING THE PIECES. THIS HAD APPARENTLY HAPPENED SEVERAL TIMES AT SEVERAL OF MUSC LOCATIONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803911 ↗
• MalfunctionMar 31, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE INSULATION THAT COVERS THE PENCIL TIP BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739662 ↗
• MalfunctionMar 18, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE CLEAR PLASTIC PIECE THAT IS ON THE PENCIL TIP PULLS OFF AFTER A FEW WIPES OF THE TIP. ALL THREE LOTS HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634480 ↗
• MalfunctionMar 18, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE CLEAR PLASTIC PIECE THAT IS ON THE PENCIL TIP PULLS OFF AFTER A FEW WIPES OF THE TIP. ALL THREE LOTS HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24625123 ↗
• MalfunctionMar 18, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE CLEAR PLASTIC PIECE THAT IS ON THE PENCIL TIP PULLS OFF AFTER A FEW WIPES OF THE TIP. ALL THREE LOTS HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24625113 ↗
• MalfunctionMar 16, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON WAS USING THE INSULATED BLADE ELECTRODE BOVIE TIP WHEN HE NOTICED THAT THE PLASTIC COVERING OF THE INSULATED TIP HAD SLID OFF INTO THE SURGICAL WOUND. THE ENTIRE BOVIE TIP AND PLASTIC COVERING WERE RETRIEVED AND PASSED OFF OF THE SURGICAL FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605565 ↗
• MalfunctionMar 13, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE SETUP DURING THE PROCEDURE, THE INSULATED TIP ON THE DEVICE WAS LOOSE AND COMING OFF. THERE WAS NO X-RAY DONE AS THE INSULATED PART DID NOT GO INTO THE PATIENT AND WAS NOTED BY THE NURSES SETTING UP AND THE SURGEON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597851 ↗
• MalfunctionMar 13, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING BREAST REVISION SURGERY WITH THE USE OF THE DEVICE, THE CLEAR INNERMOST SHEATH DETACHED FROM THE ELECTRODE WHILE BEING WIPED. THE DETACHMENT WAS IMMEDIATELY RECOGNIZED BY THE SURGEON, PREVENTING THE POTENTIAL FOR A RETAINED SURGICAL ITEM. NOTHING FELL ON PATIENT'S CAVITY, AS THE BROKEN PIECE WAS FOUND ON THE SURGICAL DRAPES. NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597683 ↗
• MalfunctionMar 13, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE'S CLEAR INNERMOST SHEATH DETACHED FROM THE ELECTRODE WHILE BEING WIPED. THE BROKEN PIECE FELL INTO THE PATIENT¿S CAVITY BUT WAS ABLE TO RETRIEVED/LOCATE WITHOUT X-RAY. NO ADDITIONAL MEDICAL PROCEDURE WAS NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589683 ↗
• MalfunctionMar 12, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE CLEAR PLASTIC PIECE ON THE PENCIL TIP PULLS OFF AFTER A FEW WIPES OF THE TIP. ALL THREE LOTS HAD THE SAME ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24580439 ↗
• MalfunctionMar 12, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE CLEAR PLASTIC PIECE ON THE PENCIL TIP PULLS OFF AFTER A FEW WIPES OF THE TIP. ALL THREE LOTS HAD THE SAME ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24577825 ↗
• MalfunctionMar 12, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE CLEAR PLASTIC PIECE ON THE PENCIL TIP PULLS OFF AFTER A FEW WIPES OF THE TIP. ALL THREE LOTS HAD THE SAME ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24577814 ↗
• MalfunctionFeb 24, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE COVER OF THE ELECTRODE DETACHED, IT HAD INSUFFICIENT ADHESION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429023 ↗
• MalfunctionFeb 23, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLEAR INSULATION OF THE ELECTRODE FELL INTO THE PATIENT'S CAVITY/BODY. IT WAS FULLY RETRIEVED BUT X-RAY WAS NOT REQUIRED TO ASSIST IN LOCATING THE PIECES. THIS HAD APPARENTLY HAPPENED SEVERAL TIMES AT SEVERAL OF MUSC LOCATIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415816 ↗
• InjuryFeb 23, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLEAR INSULATION OF THE ELECTRODE FELL INTO THE PATIENT'S CAVITY/BODY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415281 ↗
• MalfunctionFeb 23, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ELECTRODE WAS TAKEN FROM THE SHELF AND THE CLEAR INSULATION WAS EASILY REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413865 ↗
• MalfunctionFeb 16, 2026Fire; Melted; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS DEVICE FIRE AND INSULATION TIP MELTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344464 ↗