Edge E2350HRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884524000626), received between Dec 21, 2017 and Dec 29, 2025 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Fire” (9 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Device Remains Activated; Failure to Cut; Device Remains Activated; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE YELLOW CUT BUTTON WAS PRESSED TO USE THE DEVICE, IT REMAINED PUSHED IN AND DID NOT RETURN (IN A STATE OF CONTINUOUS POWER SUPPLY). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904679 ↗
• MalfunctionJul 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE SURGERY, A BURN WAS LOCATED ON THE PATIENT.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 22629187 ↗
• MalfunctionMay 19, 2025Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A FACE GROWTH REMOVAL, THE DEVICE ACTIVATED SMALL FLAME AS SOON AS THE BUTTON WAS PRESSED. IT WAS EXTINGUISHED BY WATER. PHOTOS WAS SUBMITTED SHOWING DRAPE CAUGHT ON FIRE. THE PATIENT SUFFERED A MILD REDNESS AND SLIGHT BURN TO THE TIP OF THE NOSE AND THE BASED OF THE NOSTRILS (2 CM). DAILY MEDICATION WAS THE TREATMENT DONE TO THE PATIENT. THE PATIENT HAD BEEN DISCHARGED AND IS FINE.

  Patient problems: Burn(s)

  MAUDE report 22043582 ↗
• MalfunctionApr 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE TIP HAD DETACHED. THE SURGERY WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO ABNORMALITIES IN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810168 ↗
• MalfunctionDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD BURN.

  Patient problems: Burn(s)

  MAUDE report 21026489 ↗
• MalfunctionDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PENCIL'S HANDLE PART WAS HEATED AND CAME IN CONTACT WITH THE PATIENT'S SKIN THAT CAUSED A 1 - 1.5CM OF FIRST DEGREE BURN (REDNESS) ON THE ABDOMEN AREA. NO TREATMENT IN PARTICULAR WAS DONE TO TREAT THE BURN. THERE WAS NO MEDICAL OR SURGICAL PROCEDURE BE REQUIRED TO PREVENT PERMANENT DYSFUNCTION. THE PATIENT WAS NOT HOSPITALIZED OR HAD PROLONGED HOSPITALIZATION DUE TO THE EVENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20903006 ↗
• MalfunctionNov 8, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BREAST REDUCTION, THE DEVICE COATING TIP CAME OFF. THE DEVICE WAS RETRIEVED AND DID NOT FALL INTO PATIENT SO NO X-RAY NOR ADDITIONAL MEDICAL PROCEDURE WAS NECESSARY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20641154 ↗
• MalfunctionOct 9, 2024Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE HAND SWITCH WAS UNRESPONSIVE. IT WAS REPLACED WITH NEW E2350H. THERE WAS NO PATIENT INV OLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THE PENCIL GAVE OFF AN ALARM WHEN CONNECTED TO THE SELF-ACTIVATION BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409299 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING RIGHT INGUINAL HERNIA PROCEDURE, THE SURGICAL FIELD CLEANED, AND DRIED WITH TOWELS, PATIENT WAS COVERED WITH A STERILE DRAPE. KIRCHNER WIRE INSERTED INTO THE LEFT BONE. SECOND TO THIRD DEGREE BURN ON THE RIGHT THIGH, WITH FOCAL NECROSIS ON THE SKIN OF THE SCROTUM, TWO FOCAL BURNS ON THE SECOND THIGH, AND A COIN-SIZED BURN ON THE BUTTOCK SKIN. NEUTRAL PLATE ON THE LEFT SIDE OF THE TORSO. MONOPOLAR KNIFE USED WITH 40-50W. THE PATIENT EXTEND HOSPITALIZATION SEVERAL DAYS FOR BURN CARE/TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis; Partial thickness (Second Degree) Burn

  MAUDE report 18615092 ↗
• MalfunctionJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD 6% OF 1-2 DEGREE BURNED ON PLANNED PUBIC HAIR ON ANTERIOR SURFACE OF THE ABDOMINAL CAVITY. DISPOSABLE HANDSWITCH WAS USED BUT THE BURN OCCURRED IN A DIFFERENT LOCATION THAN THE AREA WHERE THE ENERGY WAS UTILIZED. UNIVERSAL RETURN ELECTRODE HAD ALSO BEEN USED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18573997 ↗
• MalfunctionJan 3, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD BEEN REGISTERED, BUT THERE WAS A BLUE FOREIGN OBJECT ATTACHED TO THE GAUZE. THE PART FELL INTO THE PATIENT'S ABDOMINAL CAVITY BUT RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441080 ↗
• MalfunctionDec 6, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE ELECTRODE TIP CAUGHT FIRE WHEN ACTIVATED. TIP AND MONOPOLAR PENCIL WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278816 ↗
• MalfunctionMay 15, 2023Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AFTER, ROUGHLY 10 MORE MINUTES OF USE AT 70W SETTING THE DEVICE PENCIL AND ELECTRODE WAS PLACED INTO THE HOLSTER. AFTER A SHORT PERIOD IT WAS NOTICED THAT THE ELECTRODE WAS MELTING THRU THE BOTTOM OF THE HOLSTER. PULLED THE PENCIL OUT OF THE RECEPTACLE THEN PULLED THE HOLSTER UP OFF THE PATIENT. BY THEN THE ELECTRODE HAD BURNED A COMPLETE HOLE THRU HOLSTER AND LIT THE PLASTIC INSTRUMENT DRAPE THAT THE HOLSTER WAS PLACED IN CAUGHT FIRE. IT WAS DOUSED WITH WATER AND QUICKLY EXTINGUISHED. ENGINEERING EXAMINED AND RAN DIAGNOSTICS ON UNIT AFTER CASE AND COULD NOT FIND ANYTHING OUT OF THE ORDINARY. HOLSTER AND INSTRUMENT WAS PULLED AWAY FROM PATIENT AND SMALL FIRE PUT OUT QUICKLY. THERE WAS NO DIRECT PATIENT INVOLVEMENT. THE SIZE OF THE FIRE WAS LIKE A MATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936442 ↗
• MalfunctionFeb 16, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP PROCEDURE, THE PENCIL WITH ELECTRODE IGNITED WITH A SMALL FLAME, OUTSIDE OF THE PATIENT. THE FIRE WENT OUT ON IT¿S OWN, STAFF SAID THERE WAS A LOT OF FAT ON THE ELECTRODE, AND THE ELECTRODE IGNITED WHEN IT WAS NOT ACTIVATED. THE ELECTRODE HAS SOME BLACK ESCHAR ON THE COATING, BUT DID NOT FEEL LIKE THE COATING WAS BROKEN. GENERATOR SETTINGS WERE 60/60, 60 COAG WAS BEING USED. BIOMED CHECKED OUT THE GENERATOR AND DID NOT THINK ITS A GENERATOR ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386949 ↗
• MalfunctionSep 27, 2022Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TEFLON COATING APPEARED TO BE PEELING OFF THE PENCIL. THERE WAS NOTHING FELL INTO PATIENTS CAVITY. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15490867 ↗
• MalfunctionApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BREAST SURGERY, THERE WAS NO ISSUE NOTED WITH THE PENCIL, BUT THE PATIENT HAD TWO 1ST DEGREE BURNS ON THE LEFT BREAST WITH A WIDTH OF A PENCIL. THE BURN LOCATION WAS WHERE THE METAL DEAVER RETRACTOR WAS IN CONTACT WITH THE PATIENTS SKIN, IT WAS TREATED WITH BURN OINTMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 14189414 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE FIXING PART OF THE HOLDER WAS BROKEN. THE RED LINE PART IN THE ATTACHED PHOTO GOT BROKE, THE PART BROKE INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440402 ↗
• MalfunctionJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE PENCIL TIP CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206341 ↗
• MalfunctionDec 21, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BLUE AND YELLOW BUTTONS WERE PRESSED TO CHECK THE CONNECTION OF THE HAND PIECE, BUT NEITHER RESPONDED (THERE WAS NO SOUND OF ENERGIZATION). WHEN THE REPORTED HAND PIECE WAS PLACED ON THE MAYO TABLE AND OTHER PREPARATIONS WERE BEING MADE, THE SOUND OF ENERGIZATION WAS HARED. THE SCRUB NURSE DID NOT TOUCH THE DEVICE AT ALL. THEY THOUGHT IT WAS SUSPICIOUS, SO THEY REMOVED THE CORD FROM THE GENERATOR. THEY CONNECTED THE REPORTED HAND PIECE TO ANOTHER VLFT10GEN GENERATOR AND PLACED IT ON THE MAYO TABLE WITHOUT CHECKING THE POWER SUPPLY. AFTER A SHORT WHILE, THE ENERGIZATION SOUND WAS HEARD AGAIN. THIS TIME, THE SCRUB NURSE DID NOT TOUCH THE REPORTED HAND PIECE TOO, SO THE PRODUCT WAS REPLACED WITH A NEW ONE. AFTER THE REPLACEMENT, THE SOUND OF ENERGIZATION WAS CONFIRMED, AND THE DEVICE COULD BE USED CLINICALLY WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056634 ↗
• MalfunctionAug 27, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY PROCEDURE, THE ACTIVATION TONE WAS SOUNDED EVEN WHEN THE ACTIVATION BUTTON WAS NOT PRESSED. THEY REPLACED IT WITH ANOTHER SIMILAR DEVICE AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379978 ↗
• MalfunctionApr 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS NOTED THAT PART OF THE HOLSTER CAME OFF. THE DEVICE HAD INSUFFICIENT ADHESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617501 ↗
• MalfunctionOct 24, 2020Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PENCIL WAS NOT CUTTING AS IT TYPICALLY DID AND WAS SLOW AND INADEQUATE. CORDS WERE CHECKED, AND IT WAS OBSERVED THAT THE TONES DID NOT SOUND LIKE THE USUAL PENCIL DURING ACTIVATION. THE SURGEON TRIED TO CONTINUE WITH PROCEDURE, BUT WAS NOT GETTING TISSUE EFFECT AND ASKED TO HAVE CUT/COAG TURNED UP FROM 25/25 (TYPICAL SETTING) TO 40/40. THE ISSUE PERSISTED AND THE OTHER TIP WAS OPENED AND INSERTED IN ORIGINAL PENCIL WITH SAME RESULTS. THE SURGEON FINISHED THE PROCEDURE WITH THE 2ND TIP NOT FUNCTIONING/CUTTING WELL, AT A SETTING OF 40/40. THE PATIENT DEVELOPED A HEMATOMA POST OPERATIVELY WHICH WAS OBSERVED AT CHECK UP. THE PATIENT HAD A BLEEDING LESS THAN 250CC AND DEVELOPED A HEMATOMA POST OP WHICH WAS OBSERVED AT FIRST POST OP CHECK UP.

  Patient problems: Hematoma

  MAUDE report 10731714 ↗
• MalfunctionOct 3, 2020Energy Output Problem; Detachment of Device or Device Component; Energy Output Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SWITCH PART WAS FOUND DAMAGED WHEN CHECKING THE ELECTRIC PENCIL. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC EVALUATION OF THE RETURNED DEVICE FOUND THAT THE ROCKER WAS BROKEN BUT PART WAS STILL IN THE PENCIL BODY AND THE OTHER PART HAD DETACHED. THE DETACHED PART WAS RETURNED WITH THE PENCIL.

  Patient problems: No Patient Involvement

  MAUDE report 10624496 ↗
• MalfunctionAug 24, 2020Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CAUTERY PENCIL ROCKER SWITCH STAYED ON. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441041 ↗
• MalfunctionAug 6, 2020Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INCIDENT OCCURRED AT THE BEGINNING OF THE SURGERY ON THE TIP OF THE PENCIL, WHICH LED TO GENERATING A SPARK AND CAUSING A GRADE 2 BURN TO THE PATIENT IN THE AREA OF THE LEFT CLAVICLE WITH A LENGTH OF5 X 3 CM THAT COULD BE QUENCHED WITH WATER AND WET GAUZE. THE GENERATOR HAD POWERS OF 40 FOR BOTH CUTTING AND COAGULATION.

  Patient problems: Burn(s)

  MAUDE report 10375500 ↗