Edge E1455NSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10884521037137), received between Jan 25, 2019 and May 27, 2026 — classified as 6 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (41 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PLASTIC INSULATION COVER FROM CAUTERY PENCIL INSULATED TIP FELL OFF. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296389 ↗
• MalfunctionMay 20, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ELECTRODE'S INSULATED TIP THAT SHOULD STAY CONNECTED TO CAUTERY WAS FALLING OFF WHEN REMOVING COVER OF CAUTERY AND WAS STUCK INSIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230041 ↗
• MalfunctionMay 5, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE HAS A CLEAR INSULATION THAT WAS SUPPOSED TO STAY ON THE BLADE, BUT ONCE THE PROTECTIVE PLASTIC PIECE WAS TAKEN OFF, THE INSULATION WAS COMING OFF WITH IT. THE INSULATION HAS A PIECE OF SHRINK WRAP AROUND TO KEEP IT IN PLACE, BUT IT WAS NOT HOLDING THE INSULATION ON THE BLADE AND WAS STILL LOOSE IN THE COVER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086787 ↗
• InjuryMar 9, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE BLUE PLASTIC PROTECTIVE COVERING ON THE ELECTRODE BLADE SLID OFF. THE COVERING WAS IMMEDIATELY IDENTIFIED, RETRIEVED, AND REPLACED. THERE WERE NO DEVICE COMPONENTS RETAINED IN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24544818 ↗
• InjuryMar 9, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE BLUE PLASTIC PROTECTIVE COVERING ON THE ELECTRODE BLADE SLID OFF. THE COVERING WAS IMMEDIATELY IDENTIFIED, AN X-RAY WAS PERFORMED TO RETRIEVED THE PIECE AND THERE WERE NO DEVICE COMPONENTS RETAINED IN THE PATIENT. THERE WERE NO ADDITIONAL MEDICAL PROCEDURE NEEDED. THE COVERING WAS THEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24544781 ↗
• MalfunctionFeb 23, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSULATED TIP WAS COMING OFF WHEN CHANGING OUT THE PENCIL TIP AND THE TIP WAS NOT WORKING AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414388 ↗
• MalfunctionJan 28, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE DEVICE HAD MISSING CLEAR COATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196877 ↗
• InjuryJan 27, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLEAR INSULATED PIECE OF THREE ELECTRODE BLADE FELL OFF INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24196852 ↗
• InjuryJan 27, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLEAR INSULATED PIECE OF THREE ELECTRODE BLADE FELL OFF INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24196841 ↗
• MalfunctionDec 11, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, A DEVICE IN A PACK HAD A PLASTIC TIP CAME OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777599 ↗
• MalfunctionDec 11, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE IN A PACK HAD A PLASTIC TIP CAME OFF.

  Patient problems: Insufficient Information

  MAUDE report 23777555 ↗
• MalfunctionOct 16, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE BOVIE TIP HAD FELL APART. IT WAS NOTICED RIGHT AWAY AND IT WAS ABLE TO FIND THE CLEAR INSULATION SHEATH THAT HAD FALLEN OUT OFF THE BOVIE TIP. IMMEDIATELY DISCONTINUED THE USE OF THE BOVIE TIP AND REPLACED THE BOVIE TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310026 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP COVERS OF THE ELECTRODE WAS FALLING OFF PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047938 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP COVERS OF THE ELECTRODE WAS FALLING OFF PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047937 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SHEATH TIP OF THE ELECTRODE WAS PUSHED DOWN ON THE PROTECTED TIPS PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047934 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SHEATH TIP OF THE ELECTRODE WAS PUSHED DOWN ON THE PROTECTED TIPS PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047931 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SHEATH TIP OF THE ELECTRODE WAS PUSHED DOWN ON THE PROTECTED TIPS PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047928 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SHEATH TIP OF THE ELECTRODE WAS PUSHED DOWN ON THE PROTECTED TIPS PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047927 ↗
• MalfunctionSep 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SHEATH TIP OF THE ELECTRODE WAS PUSHED DOWN ON THE PROTECTED TIPS PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047926 ↗
• InjuryAug 6, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST RECONSTRUCTION USING A DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) FLAP PROCEDURE, A SMALL CLEAR PLASTIC PIECE BECAME DISLODGED FROM THE CAUTERY TIP WHEN CAUTERY WAS NOT IN USE. THIS PARTICULAR PLASTIC COMPONENT WAS NOT KNOWN TO COME OFF OR BE LOOSE UNDER NORMAL CONDITIONS, SO ITS DETACHMENT WAS UNEXPECTED. THESE TIPS WERE NOT INDIVIDUALLY WRAPPED BUT ARE PACKAGED IN A SMALL ZIP-LOCK STYLE BAG WITH OTHER SMALL ITEMS WITHIN THE SURGICAL PACK. THEY NOTED THE MISSING PIECE AND IMMEDIATELY ALERTED THE SURGEON. A THOROUGH SEARCH OF THE STERILE FIELD WAS CONDUCTED BUT THE PIECE COULD NOT BE LOCATED. AN INTRAOPERATIVE X-RAY WAS PERFORMED; THE IMAGING SHOWED NO FOREIGN OBJECTS TO BE FOUND. THE PROCEDURE WAS COMPLETED AS NORMAL.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22734707 ↗
• InjuryJul 30, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST RECONSTRUCTION USING A DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) FLAP PROCEDURE, A SMALL CLEAR PLASTIC PIECE BECAME DISLODGED FROM THE CAUTERY TIP WHEN CAUTERY WAS NOT IN USE. THIS PARTICULAR PLASTIC COMPONENT WAS NOT KNOWN TO COME OFF OR BE LOOSE UNDER NORMAL CONDITIONS, SO ITS DETACHMENT WAS UNEXPECTED. THESE TIPS WERE NOT INDIVIDUALLY WRAPPED BUT WERE PACKAGED IN A SMALL ZIP-LOCK STYLE BAG WITH OTHER SMALL ITEMS WITHIN THE SURGICAL PACK. THEY NOTED THE MISSING PIECE AND IMMEDIATELY ALERTED THE SURGEON. A THOROUGH SEARCH OF THE STERILE FIELD WAS CONDUCTED BUT THE PIECE COULD NOT BE LOCATED. AN INTRAOPERATIVE X-RAY WAS PERFORMED; THE IMAGING SHOWED NO FOREIGN OBJECTS TO BE FOUND. THE PROCEDURE WAS COMPLETED AS NORMAL.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22666460 ↗
• MalfunctionJul 28, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE PROTECTIVE COATING ON THE BOVIE TIP WAS COMPROMISED, WHICH RESULTED IN A BURN TO THE PATIENT. THE FACILITY STATED THAT THE TIP WAS NOT INSULATED. DURING USE OF THE BOVIE GENERATOR, SURROUNDING TISSUE WAS BURNED IN 2-3 SPOTS ALONG THE PATIENT'S INCISION, CAUSING MINOR BURNS TO THE EPIDERMIS. THIS LED TO A DELAY IN THE PROCEDURE OF APPROXIMATELY 3 MINUTES AND REQUIRED THE USE OF ADDITIONAL RESOURCES. THE AFFECTED TISSUE WAS ADDRESSED BY THE PHYSICIAN WITHOUT FURTHER ISSUES TO THE PATIENT. IT WAS NOTED THAT A SECOND PACKAGE ALSO HAD AN AFFECTED BOVIE TIP BUT WAS NOT USED ON THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22634383 ↗
• MalfunctionJul 24, 2025Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING USE, THE PENCIL AND THE ELECTRODE HAD FIRE INCIDENT. ARCHING HAD OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588404 ↗
• MalfunctionJun 20, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT PRIOR TO USE, THE BOVIE TIP WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297618 ↗
• MalfunctionJun 9, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO USE, THE PLASTIC INSULATION FELL OFF THE CAUTERY TIP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171574 ↗