Edge E2350HGNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884524002217), received between Jun 8, 2017 and Feb 12, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fire” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Peeled/Delaminated; Detachment of Device or Device Component; Insufficient Device Problem Information

  DUPLICATE OF PE: (B)(4) IT WAS REPORTED THAT THE CLEAR PLASTIC SLEEVE ON THE TIP OF THE DEVICE WAS BREAKING OFF. REPORTED UNDER (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 24322066 ↗
• MalfunctionJan 28, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLEAR PLASTIC SLEEVE ON THE TIP OF THE DEVICE WAS BREAKING OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197005 ↗
• MalfunctionOct 30, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE THAT CAME IN THE LAMINECTOMY AND CRANI PACKS FELL APART AT THE TIP. THE PLASTIC COULD GO UNDETECTED AND COULD BECOME A RETAINED FOREIGN BODY DUE TO THE FACT THAT IT WAS CLEAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422353 ↗
• MalfunctionOct 27, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE THAT COMES IN THE LAMINECTOMY AND CRANI PACKS FELL APART AT THE TIP. THE PLASTIC COULD GO UNDETECTED AND COULD BECOME A RETAINED FOREIGN BODY DUE TO THE FACT THAT IT IS CLEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390749 ↗
• MalfunctionJun 9, 2025Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, THE PROVIDER HOLDING THE PEN REPORTED A SHOCK TO THE HAND. BOVIE WAS REPLACED (PAD AND PEN) AND CONTINUED. IT RESULTED IN MILD BURN TO THE HAND THAT DID NOT REQUIRE TREATMENT. PROVIDER CHANGED GLOVES.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 22165327 ↗
• MalfunctionJun 9, 2025Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CESAREAN SECTION, THE PROVIDER HOLDING THE PEN REPORTED A SHOCK TO THE HAND. BOVIE WAS REPLACED (PAD AND PEN) AND CONTINUED THE SURGERY. THE PHYSICIAN ALSO CHANGED GLOVES. THE SURGEON HAD SECOND DEGREE SUBCENTIMETER BURN TO THE HAND THAT DID NOT REQUIRE TREATMENT.

  Patient problems: Electric Shock; Partial thickness (Second Degree) Burn

  MAUDE report 22165250 ↗
• MalfunctionMar 13, 2023Fire; Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE CAUTERY PENCIL IGNITED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534852 ↗
• MalfunctionJan 5, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BOVIE HOLDERS BROKE OFF COMPLETELY.

  Patient problems: Insufficient Information

  MAUDE report 16102350 ↗
• MalfunctionMay 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PIECE OF THE TIP OF THE CAUTERY PENCIL BROKE OFF AND FELL INTO THE INCISION SITE. IT WAS RETRIEVED WITH THE USE OF FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526362 ↗
• MalfunctionNov 22, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE EMITTED 4-5 MILLIMETER FLAMES THAT WENT OUT ON ITS OWN. THERE WAS NO FIRE IN THE OPERATING ROOM, AND THE DOCTOR USED A DIFFERENT PENCIL WITH THE SAME GENERATOR, WHICH WORKED PERFECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851166 ↗
• MalfunctionSep 13, 2021Therapeutic or Diagnostic Output Failure; Excessive Heating

  THE CAUTERY PENCIL WAS WORKING IMPROPERLY AND THE TIP WAS TO HOT TO USE. THERE WAS PATIENT CONTACT BUT NO HARM TO THE PATIENT. NO DELAY TO THE CASE. ANOTHER CAUTERY WAS PULLED FROM STERILE STOCK AND USED FOR THE PROCEDURE. THE CAUTERY PENCIL IS A COMPONENT CONTAINED WITHIN A CUSTOM PROCEDURE KIT BUILT BY ROI CPS, LLC. KIT 880030015, LOT 891190.

  Patient problems: Insufficient Information

  MAUDE report 12463451 ↗
• MalfunctionAug 25, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, CAUTERY TIP HAD SIGNIFICANT FLAME AFTER COAGULATION BUTTON WAS RELEASED AND HAD BEEN REMOVED FROM PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366979 ↗
• MalfunctionFeb 26, 2021Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY, THE DEVICE'S TIP CAUGHT ON FIRE AND THE DOCTOR HAD A 2ND DEGREE BURN TO HIS LEFT RING AND MIDDLE FINGERS. THERE WAS SOME DELAY IN THE CASE AS THE SURGEON HAD TO CHANGE GLOVES AND TAKE CARE OF HIS FINGERS. NO MEDICAL CARE OR TREATMENT OF SURGEON WAS REQUIRED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11385894 ↗
• MalfunctionFeb 24, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING AN AXILLARY NODE DISSECTION, THE CAUTERY TIP CAUGHT FIRE. IT HAD BEEN USED TO DISSECT TISSUE EARLIER IN THE CASE, AT THE TIME IT CAUGHT FIRE IT WAS BEING HELD AGAINST A METAL INSTRUMENT TO CAUTERIZE A VESSEL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371811 ↗
• MalfunctionFeb 23, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEONS WERE BUZZING TISSUE WHICH WAS GRASPED WITH A CLAMP AND THE TIP OF THE ELECTRODE FLAMED UP. THE FLAME CAME FROM THE PENCIL AND CONTINUED TO BURN AWAY THE COATING OF THE ELECTRODE AFTER IT WAS ACTIVATED. THERE WAS NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364790 ↗
• MalfunctionOct 18, 2018Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PENCIL CAUGHT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: Full thickness (Third Degree) Burn; No Consequences Or Impact To Patient

  MAUDE report 7978794 ↗
• MalfunctionSep 12, 2018Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CAUTERY KEPT FIRING AFTER BUTTON RELEASE. FURTHER INFORMATION NOT AVAILABLE.

  Patient problems: No Information

  MAUDE report 7869196 ↗
• MalfunctionJun 8, 2017Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED WHEN THE BOVIE IS PUT IN THE ¿ON¿ POSITION THEY CANNOT TURN IT OFF AND NEED TO DISCARD IT AND RETRIEVE ANOTHER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621959 ↗
• MalfunctionJun 8, 2017Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED WHEN THE BOVIE IS PUT IN THE ¿ON¿ POSITION THEY CANNOT TURN IT OFF AND NEED TO DISCARD IT AND RETRIEVE ANOTHER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621935 ↗