Edge E2450HGNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884524002248), received between Jun 7, 2017 and Mar 23, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Fire” (21 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A FIRE OCCURRED IN ONE OF THE OPERATING ROOMS, AND THE SURGEON WONDERED IF IT COULD HAVE BEEN CAUSED BY THE BOVIE TOUCHING AN X-RAY DETECTABLE LAP SPONGE. THE BOVIE STARTED THE FIRE (NO FLAME) THAT PRODUCED A 2 IN ROUND HOLE IN THE LAP SPONGE. THE SPONGE WAS TOSSED ONTO THE FLOOR. IN THE GENERAL PACK, A BOVIE PENCIL WAS USED ALONG WITH AN X-RAY DETECTABLE LAP SPONGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661940 ↗
• MalfunctionJun 24, 2025Fire; Arcing; Fire; Arcing

  IT WAS REPORTED THAT DURING USE, THE DEVICE PRODUCED A RED FIRE AND SPARK. DISCONTINUED THE USE AND REPLACED WITH A NEW ONE FROM OPERATING ROOM SUPPLY ROOM, WHICH WAS USED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319683 ↗
• MalfunctionJun 24, 2025Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING C-SECTION, THE DEVICE PRODUCED A RED FIRE AND SPARK. IT WAS DISCONTINUED AND REPLACED WITH A NEW ONE WHICH WAS USED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319623 ↗
• MalfunctionJun 18, 2025Fire; Peeled/Delaminated; Fire; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE ABDOMINAL REPAIR, THE FIRST PACK CAUGHT ON FIRE UPON OPENING THE DEVICE. THEN THE PHYSICIAN AND OBSTETRIC TRIAGE (OBT) NOTICED A SMALL RED SPARK FIRE AT THE TIP OF THE BOVIE WAND WHILE IT WAS BEING USED ON THE FASCIA MUSCLE. THE WAND WAS QUICKLY REMOVED AND REPLACED WITH A NEW ONE AND THE REST OF THE ABDOMINAL CLOSURE WENT SMOOTHLY. IT WAS NOTED THAT THE USED DEVICES HAD BLACK SPOT ON THE TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282415 ↗
• MalfunctionJun 18, 2025Fire; Peeled/Delaminated; Insufficient Device Problem Information; Fire; Peeled/Delaminated; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE ABDOMINAL REPAIR, THE FIRST PACK CAUGHT ON FIRE UPON OPENING THE DEVICE. THEN THE PHYSICIAN AND OBSTETRIC TRIAGE (OBT) NOTICED A SMALL RED SPARK FIRE AT THE TIP OF THE BOVIE WAND WHILE IT WAS BEING USED ON THE FASCIA MUSCLE. THE WAND WAS QUICKLY REMOVED AND REPLACED WITH A NEW ONE, AND THE REST OF THE ABDOMINAL CLOSURE WENT SMOOTHLY. IT WAS NOTED THAT THE USED DEVICES HAD BLACK SPOT ON THE TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282271 ↗
• MalfunctionMay 29, 2025Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE BOVIE BECAME HEATED IN PROVIDERS HANDS WHEN NOT IN USE CREATING A BURN ON PROVIDERS GOWN. THERE WAS NO HARM TO THE PROVIDER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111060 ↗
• MalfunctionMay 29, 2025Overheating of Device; Arcing; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PENCIL SPARKED WHEN BUZZING A TONSIL CLAMP. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22110962 ↗
• MalfunctionSep 25, 2024Fire; Difficult or Delayed Activation; Arcing; Fire; Difficult or Delayed Activation; Arcing

  ACCORDING TO THE REPORTER, THE PENCIL CAUTERY WAS WORKING INTERMEDIATELY (ON AND OFF SIMULTANEOUSLY). THE PENCIL GOT SPARK THAT CAUSED FIRE INTO LAP SPONGE LOCATED ON THE CHEST OF THE PATIENT. IT LEFT MARK ON THE PATIENT.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 20300760 ↗
• InjuryJan 29, 2024Fire; Fire

  ACCORDING TO THE REPORTER, DURING A BLEPHAROPLASTY CASE, THERE WAS A FIRE IN THE OPERATING ROOM (OR) IN ONE OF THE EAR, NOSE AND THROAT (ENT) SURGEONS. THE SURGEON WAS USING CAUTERY WHEN THE DRAPE IGNITED. DRAPE OVER FACE CAUGHT FIRE WITH O2 TRAPPED UNDER IT EXACERBATING THE FLAME. FIRE WAS APPROXIMATELY 6" IN DIAMETER AND JUMPED TO BELOW THE SHOULDERS DUE TO O2 POOLING IN THE AREA. THE PATIENT HAD MONITORED ANESTHESIA CARE (MAC) AND THE PROVIDER WAS USING A MASK TO DELIVER OXYGEN. THE PATIENT ENDED UP WITH 2ND DEGREE BURN AROUND MOUTH AND CHIN, TIP OF TONGUE AND THE BACK OF BOTH SHOULDERS. PATIENT WAS TREATED WITH TOPICAL AND WAS INTUBATED OVERNIGHT THEN RELEASED IN THE MORNING. BASIN OF WATER WAS USED TO EXTINGUISH FLAMES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18602527 ↗
• MalfunctionSep 24, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BOVIE WAS CAUGHT ON FIRE WHEN THE SURGEON WAS PRESSING IT AGAINST ANOTHER INSTRUMENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 15478819 ↗
• MalfunctionSep 20, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP WAS NOT INSIDE THE PATIENT WHEN THE FLAME OCCURRED. THE TISSUE WAS CLAMPED WITH A STILE CLAMP, THE CAUTERY (B)(4) WAS ABOVE THE SKIN TOUCHING THE CLAMP TO CAUTERIZE TISSUE. THE NURSE NOTICED THE TIP BEGAN SMOKING AND STARTED SPARKING AND THEN CAUGHT FIRE. THE FLAME WAS ABOUT A MATCH SIZE. IT BURNED IN A VERY SHORT TIME LIKE 5 SECONDS, SHE FANNED THE FLAME OUT.

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

  MAUDE report 15458695 ↗
• MalfunctionAug 23, 2022Fire; Fire

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE CAUTERY PENCIL CAUGHT ON FIRE. IT WAS NOT INSIDE THE PATIENT. THEY HAD THE TISSUE CLAMPED WITH A STILLE CLAMP AND WERE USING THE CAUTERY TIP TO TOUCH THE STILLE TO CAUTERIZE THE TISSUE. THERE WAS A SHORT DELAY OF 5 MINUTES OR LESS. THE TIP OF THE CAUTERY CAUGHT ON FIRE AND STAYED ON FIRE AFTER BEING REMOVED FROM THE CLAMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277342 ↗
• MalfunctionAug 19, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BOVIE WAS CAUGHT ON FIRE WHEN THE SURGEON WAS PRESSING IT AGAINST ANOTHER INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262726 ↗
• MalfunctionApr 15, 2022Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING SET UP PRIOR TO PROCEDURE, THE DEVICE¿S SWITCH WAS STUCK IN THE ¿ON¿ POSITION WHEN PLUGGED INTO THE GENERATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118673 ↗
• MalfunctionAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAP-ASSISTED SIGMOID COLECTOMY, AFTER USE OF DEVICE TO CAUTERIZED A SUPERFICIAL BLEEDER AT THE VERRES NEEDLE INSERTION SITE, THE PATIENT SUSTAINED AN APPROXIMATELY 1" OVAL-SHAPED REDDENED TISSUE NOTED ON THE ABDOMEN.

  Patient problems: Insufficient Information

  MAUDE report 12273014 ↗
• MalfunctionJan 22, 2021Fire; Fire

  ACCORDING TO THE REPORTER, THERE WAS A FLAMES COMING OUT OF BOVIE TIP.

  Patient problems: Insufficient Information

  MAUDE report 11213855 ↗
• MalfunctionJan 15, 2020Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, THE DEVICE SPARKED AND CAUGHT ON FIRE. NO INJURY TO PATIENT OR STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594187 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE BLADE OF THE WAS DEFECTIVE. THE COATING WAS PEELED OFF AND BURNT THROUGH THE SURGEON GOWN.

  Patient problems: No Information

  MAUDE report 9517986 ↗
• MalfunctionApr 17, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING OPEN HYSTERECTOMY, THE BOVIE TIP IGNITED IN FLAME DURING ACTIVATION ON TISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525588 ↗
• MalfunctionApr 17, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING OPEN TOTAL HYSTERECTOMY, THE BOVIE TIP IGNITED IN FLAME. NEW PENCIL WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525584 ↗
• MalfunctionMar 18, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON ACTIVATION, THE PENCIL TIP LIT ON FIRE LIKE A MATCH STICK. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428816 ↗
• MalfunctionMar 15, 2019Fire; Fire

  ACCORDING TO THE REPORTER, THE PENCIL TIP CAUGHT FIRE AFTER USE. NOBODY WAS INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425279 ↗
• MalfunctionFeb 18, 2019Fire; Fire

  ACCORDING TO THE REPORTER, THE PENCIL TIP CAUGHT ON FIRE AFTER BEING USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8348646 ↗
• MalfunctionSep 6, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA), THE PENCIL TIP LIT ON FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850664 ↗
• MalfunctionJul 6, 2018Arcing; Arcing

  ACCORDING TO THE REPORTER, DURING A BREAST AUGMENTATION CASE, THE CAUTERY PENCIL SPARKED AND CAUSED SUPERFICIAL FIRST-DEGREE BURN NEAR THE PATIENT'S ORIGINAL INCISION AT LEFT BREAST IN A SIZE OF A PENCIL'S ERASURE. BURN SITE WAS APPLIED WITH SILVADENE CREAM MEDICATION. GENERATOR USED WAS ON 40 CUT/40 COG SETTING.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 7667274 ↗