Edge E2450HRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10884524000022), received between Jun 8, 2017 and Feb 23, 2026 — classified as 5 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (13 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Device Alarm System; Device Remains Activated

  IT WAS REPORTED THAT PRIOR TO USE AFTER CONNECTION, AN ERROR OCCURRED AND THE SWITCH WAS ALWAYS ON/CONSTANTLY IN THE ON STATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414997 ↗
• MalfunctionOct 21, 2025Fire; Fire

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS A SMALL FLAME AT THE TIP OF THE PENCIL WHEN ACTIVATED WHILE IT WAS PLUGGED TO THE GENERATOR WITH SOFTWARE VERSION 4.0. THE FLAME WENT OUT ON ITS OWN. THE GENERATOR WAS SET TO 60 CUT/40 COAG. ERRORS E402 AND E404 WAS ALSO FOUND IN ERROR LOGS. A NEW HANDPIECE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348595 ↗
• MalfunctionAug 1, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A CLOSED HOLE BYPASS PROCEDURE, THE POWER WAS SUPPLIED EVEN AFTER RELEASING THE YELLOW BUTTON. A NEW DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688050 ↗
• MalfunctionOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DEVICE WAS USED, THE PATIENT HAD FIRST DEGREE BURN INSIDE THE LIPS. DONE TREATMENT TO THE BURN SITE.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 20472104 ↗
• MalfunctionAug 12, 2024Fire; Material Integrity Problem; Fire; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NON-MEDTRONIC GAUZE CAUGHT FIRE. FLAMES ABOUT THE SIZE OF A MATCH. CUSTOMER SHOOK OFF THE GAUZE, AND THE FLAME WAS EXTINGUISHED NATURALLY. LATER, BURNT MARKS ON THE CORD OF THE PENCIL WAS FOUND, SO IT WAS REPLACED IT WITH A NEW ONE, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. THE CAUSAL RELATIONSHIP WITH THE IGNITED GAUZE WAS UNKNOWN. NO OPERATING ROOM FIRE HAPPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967732 ↗
• MalfunctionJun 28, 2024Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, THE ASSISTANT SURGEON THEN CONNECTED THE BOVIE TO THE FORCEPS AND ACTIVATED THE COAGULATION BUTTON. BOTH PRIMARY AND ASSISTANT SURGEON NOTED THAT THE SPARK EMITTED WAS BRIGHTER THAN USUAL CAUSING THE ASSISTANT SURGEON TO PULL THE DEVICE BACK FROM THE KELLY WHILE DISENGAGING THE BUTTON. AFTER PULLING AWAY THERE WAS A SMALL FLAME EMITTING FROM THE TIP OF THE BOVIE FOR 4-5 SECONDS THAT WAS PUT OUT BY GENTLY WAVING THE BOVIE.

  Patient problems: Insufficient Information

  MAUDE report 19638993 ↗
• MalfunctionJun 27, 2024Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST RECONSTRUCTION WITH EXCHANGE OF TISSUE EXPANDERS FOR GEL IMPLANTS, PATIENT EXPERIENCED A BURN IN AN AREA NOT BEING CAUTERIZED. THE BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SUPERFICIAL 2ND DEGREE BURN TREATED WITH TOPICAL OINTMENT. BACTRIACIN ZINC-POLYMYXIN B (POLYSPORIN) AND ANTIMICROBIAL WATER RESISTANT BANDAGE (MEPILEX) AND SURGICAL BRA WAS ALSO PLACED PER USUAL PROCEDURE. CUT/COAG SETTINGS WERE 30/30. CUSTOMER ALSO REPORTED THAT THE REMOVAL OF THE ELECTRODE HAS BEEN QUITE DIFFICULT. CUSTOMER EXCHANGED ELECTRODES OFTEN THROUGHOUT THE PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19626060 ↗
• MalfunctionJun 20, 2024Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST RECONSTRUCTION WITH EXCHANGE OF TISSUE EXPANDERS FOR GEL IMPLANTS, THE DEVICE HAD ARCING/SPARKING. THE STAFF REPORTED THAT WHEN THEY CHANGED OUT THE ELECTRODE FOR THE INSULATED TIP, THE ELECTRODE WAS EXTREMELY (AND UNUSUALLY) DIFFICULT TO REMOVE FROM BOVIE PENCIL. REMOVAL OF THE ELECTRODE HAS BEEN QUITE DIFFICULT. EXCHANGED ELECTRODES OFTEN TH ROUGHOUT THE PROCEDURE. THIS CAUSED PATIENT TO EXPERIENCE A BURN IN AN AREA NOT BEING CAUTERIZED. BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SUPERFICIAL 2ND DEGREE BURN TREATED WITH TOPICAL OINTMENT. CUT/COAG SETTINGS WERE 40/40. BACTRIACIN ZINC-POLYMYXIN B (POLYSPORIN) AND ANTIMICROBIAL WATER RESISTANT BANDAGE (MEPILEX) AND SURGICAL BRA ALSO PLACED PER USUAL PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19577299 ↗
• MalfunctionJun 20, 2024Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST PROPHYLACTIC MASTECTOMY SKIN SPARING AND BILATERAL BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND BIOLOGIC MESH FOR SOFT TISSUE SUPPORT, DEVICE HAD ARCING/SPARKING ISSUE AND THE REMOVAL OF THE ELECTRODE HAS BEEN QUIET DIFFICULT. SURGEON EXCHANGED ELECTRODES OFTEN THROUGHOUT THE PROCEDURE. PATIENT EXPERIENCED A BURN ALONG THE INCISION DURING CAUTERY USE. THE BURN APPEARED TO OCCUR BY ELECTRICAL CONDUCTIVITY THROUGH THE BASE OF WHERE THE TIP OF THE CAUTERY WAS CONNECTED TO THE HAND PIECE. SURGEON NOTED BOVIE WAS NOT USED IN THAT AREA. AREA OF SKIN WAS REMOVED PER USUAL PROCEDURE NOT BECAUSE OF BURN. CUT/COAG SETTINGS WERE 40/40.

  Patient problems: Burn(s)

  MAUDE report 19577069 ↗
• MalfunctionMay 24, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER OPENING IT FROM THE PACKAGE, WHEN IT WAS CONNECTED TO THE FT10, THE CUT MODE CONTINUED TO OUTPUT EVEN THOUGH THE OUTPUT BUTTON WAS NOT PRESSED. ONLY THE DEVICE WAS REPLACED, AND THE SAME GENERATOR AND THE TIP ELECTRODE OF THE SCALPEL COULD BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393420 ↗
• MalfunctionFeb 28, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS ATTACHED TO THE GENERATOR, IT OUTPUTTED ON ITS OWN. THE ACTIVATION BUTTON OR SWITCH INDICATE AN "ON" POSITION. THE DEVICE ACTIVATED WITHOUT PRESSING THE ACTIVATION BUTTON OR SWITCH. ANOTHER PENCIL COULD BE USED IN THE FIELD, SO THIS WAS PROCESSED AS A PENCIL DEFECT.

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

  MAUDE report 18800671 ↗
• MalfunctionNov 16, 2023Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE MONOPOLAR DEVICE MADE THE ELECTRO WAVES JUMP. THE PROCEDURE WAS COMPLETED BUT PATIENT HAD A 2ND DEGREE SMALL BURN ON THE RIGHT CORNER OF THE LIP AND THE BURN WAS TREATED WITH CREAMS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18156507 ↗
• MalfunctionAug 14, 2023Failure to Deliver Energy; Peeled/Delaminated; Failure to Fire; Failure to Deliver Energy; Peeled/Delaminated; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PNEUMECTOMY, THE DEVICE DID NOT ACTIVATE WHEREIN UNIT¿S OUTPUT WAS NOT POSSIBLE ONLY FOR COAGULATION EVEN WHEN THE DEVICE WAS REPLACED. COAGULATION OUTPUTTED WITH THE THIRD HANDPIECE. THERE WAS NO PATIENT INJURY. SIX PHOTOGRAPHS WERE RECEIVED, ONE PHOTO SHOWED DAMAGED INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546983 ↗
• MalfunctionJun 29, 2023Device Alarm System; Self-Activation or Keying; Device Alarm System; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE CONNECTED TO THE DA VINCI VISION CART, THE OUTPUT SOUND SOUNDED EVEN WHEN THE OUTPUT BUTTON WAS NOT PRESSED. IT WAS DISCONNECTED ONCE AND CONNECTED AGAIN, BUT IT WAS THE SAME. IT OUTPUTTED ALSO BY ITSELF EVEN WITHOUT PRESSING THE BUTTON, SO WHEN IT WAS TRIED TO OPEN A NEW ONE OF THE SAME PRODUCT, IT HAS NO PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227700 ↗
• MalfunctionJun 12, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUT FUNCTIONED JUST BY PLUGGING IT INTO THE GENERATOR. THE BUTTON WAS NOT PRESSED. AFTER RESTARTING THE GENERATOR AND PLUGGING IT IN AGAIN, THE CUT FUNCTIONED IN THE SAME MANNER. THE DEVICE WAS REPLACED WITH A NEW ONE AND IT USED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17112250 ↗
• InjuryMay 26, 2023Device Remains Activated; Adverse Event Without Identified Device or Use Problem; Device Remains Activated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING EXPLORATORY LAP CREATION OF COLOSTOMY, DURING THE CLOSURE OF THE PATIENT, THE BOVIE CUT BUTTON BECAME STUCK IN THE ON POSITION. NURSE NOTIFIED THE SURGEON UPON HEARING THE AUDIO ALERT, AND WHEN INVESTIGATED THE SURGEON FOUND THE BOVIE HANDPIECE HAD BURNED THE PATIENT'S UPPER RIGHT ABDOMEN. REPAIR OF THE SKIN WAS DONE AT THE FIELD.

  Patient problems: Burn(s)

  MAUDE report 17010717 ↗
• MalfunctionApr 3, 2023Overheating 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 PENCIL BECAME VERY HOT QUICKLY AND TOUCHED THE FINGER OF THE TEAM MEMBER BURNING THROUGH TWO PAIRS OF GLOVES DURING AN EXPLORATORY LAPAROTOMY. TEAM MEMBER DID NOT REQUIRE TREATMENT FOR INJURY. THERE WAS NO PATIENT INJURY. ALL EQUIPMENT AND DISPOSABLES WERE REMOVED FROM SERVICE. CLINICAL ENGINEERING TESTED THE EQUIPMENT AND FOUND OUTPUT FROM UNIT TO PEN WERE WITHIN SPECIFICATIONS.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 16665113 ↗
• MalfunctionJan 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE TIP OF THE SCALPEL WAS REMOVED, THE PART WITH COPPER WIRE WAS CHIPPING AND FELL OFF. A NEW PRODUCT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270227 ↗
• MalfunctionDec 12, 2022Loose or Intermittent Connection; Self-Activation or Keying; Loose or Intermittent Connection; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INSERTION PART (3-PIN PART) WITH THE GENERATOR WAS LOOSE, SO IT WAS NOT PROPERLY FIXATED AND ONE OF THE TWO DEVICES WAS IN A STATE WHEREIN CUT WAS BEING OUTPUTTED WITHOUT PRESSING THE BUTTON. ANOTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15962360 ↗
• MalfunctionOct 31, 2022Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE SPARKED AT 1 CM FLAME WHEN ACTIVATED. COMPLETED FULL TEST OF ALL OUTPUTS FOR THE GENERATOR AND NOTHING WAS IDENTIFIED OUT OF CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705154 ↗
• MalfunctionOct 10, 2022Fire; Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SURGEON MANAGED TO IGNITE A SPONGE WITH THE TIP OF THE PENCIL WHICH THEN MELTED IN THE TEST TUBE THAT WAS BEING USED IN CONJUNCTION WITH THE GENERATOR. THIS TOOK PLACE IN THE CHEST CAVITY, NOT OUTSIDE THE BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15570277 ↗
• MalfunctionAug 18, 2022Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS AN ARCING FROM THE ATTACHED PENCIL. THE PATIENT HAD A BURN.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 15250977 ↗
• MalfunctionAug 17, 2022Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE BOVIE PENCIL AND FT-10, THE FT10 GOT STUCK IN CUT MODE. WHILE THE PENCIL WAS IN THE HOLSTER, THE PATIENT HAD FIRST DEGREE BURN ON THE ELBOW WHICH WAS EXTREMELY SMALL.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15240862 ↗
• MalfunctionJul 11, 2022Self-Activation or Keying; Failure to Fire; Communication or Transmission Problem; Self-Activation or Keying; Failure to Fire; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, DURING OPEN GASTRECTOMY, THE POWER DID NOT ACTIVATE EVEN THOUGH THE ACTIVATION BUTTON WAS PRESSED. A NEW HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THERE WAS A RESISTANCE READING ON THE MULTIMETER FOR THE COAG ACTION WITHOUT THE BUTTON BEING PRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976638 ↗
• MalfunctionJun 22, 2021Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THORACOTOMY, THE UNIT ARCED. THE PHYSICIAN HAD 2ND DEGREE BURN ON HIS LEFT INDEX FINGER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 12044721 ↗