Valleylab E2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884524000497), received between Nov 18, 2018 and Dec 23, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE VALLEYLAB DISPOSABLE MONOPOLAR PEN HAD A DEFECTIVE COAGULATION BUTTON THAT REMAINED PERMANENTLY ACTIVATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875096 ↗
• MalfunctionDec 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DISPOSABLE MONOPOLAR PEN HAD A DEFECTIVE COAGULATION BUTTON THAT REMAINED PERMANENTLY ACTIVATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850685 ↗
• MalfunctionJun 5, 2025Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  ACCORDING TO THE REPORTER PRIOR TO USE, THE PENCIL WOULD NOT WORK. INITIALLY, THE ELECTROSURGERY CONSOLE WAS CHANGED, BUT IT WAS VERIFIED THAT IT WAS THE PEN THAT DID NOT WORK. THE UROLOGIST AND THE INSTRUMENTALIST, A NEW PEN WAS REQUESTED IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE SWITCH RESISTANCE FAILURE WAS FOUND. THERE WAS A READING WITHOUT PRESSING THE CUT BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149512 ↗
• MalfunctionOct 24, 2023Failure to Cut; Appropriate Device Problem Term/Code Not Available; Failure to Cut; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING CAESARIAN SECTION, THE PENCIL WAS FAULTY, THE "CUT BUTTON" DOESN'T WORK, IMPOSSIBLE TO CUT. NO ELECTRICAL CONTACT. THE PROCEDURE WAS CANCELLED. PATIENT WAS UNDER ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996419 ↗
• MalfunctionMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN INCREASED MAMMOPLASTY WITH INSTALLATION OF PROTESIS, THE DEVICE HAD AN INSULATION ISSUE. THE SU RGEON WAS IN THE MIDDLE OF THE SURGERY, THEY REFERRED TO USE IT ON A NORMAL FREQUENCY FOR BREAST IMPLANT SURGERY, AND COMMENTED THAT THERE WAS NO CONSTANT USE. WHEN USING THE ELECTROBISTURI AND ACTIVATING IT THEY PERFORMED AN ARC GENE BURN WITH THE POSTERIOR PART CAUSED A GRADE 2 RIGHT NIPPLE 7X10 MM BURN. THE CAUSED OF THE BURN WAS FROM AN OPENING FROM THE SIDE OF THE INSTRUMENT. THEY APPLIED PHYSIOLOGICAL SERUM AND IT WAS COVERED WITH GAUZE. A PRODUCT EXCHANGE WAS MADE FROM ANOTHER BRAND.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16487094 ↗
• MalfunctionJun 30, 2022Inappropriate/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 GYN PROCEDURE, THE DOCTOR RECEIVED A SLIGHT ELECTRICAL ZAP THROUGH THE GLOVE WHEN ACTIVATED THE BOVIE PENCIL. DOCTOR GOT A FIRST DEGREE ELECTRICAL BURN AT THE RIGHT THUMB WITH NO REDNESS OBSERVED BUT HAD A LITTLE NUMBNESS. THE GENERATOR WAS WORKING FINE.

  Patient problems: Numbness; Superficial (First Degree) Burn

  MAUDE report 14879596 ↗
• MalfunctionMar 1, 2022Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD INTERMITTENT ACTIVATION. IT WAS IDENTIFIED THAT THE DEVICE WAS MALFUNCTIONING, IT WORKED BY ITSELF WITHOUT ACTIVATING THE FOOT PEDAL OR BUTTON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636753 ↗
• MalfunctionAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF BILATERAL VARICOCELECTOMY AND BILATERAL HYDROCELE ON BILATERAL INFRAINGUINAL INCISION SITE, PRIOR TO DISCHARGE, THE PATIENT WAS FOUND TO HAVE 4-5MM BURN SCAB ON RIGHT THIGH. THE BURN MARK WAS ON PATIENT'S RIGHT THIGH WHEREIN THE REM PAD WAS ON LEFT THIGH AND CORDS PATH IN THE PROCEDURE WAS ALSO ON THE LEFT SIDE OF THE PATIENT. THE GENERATOR WAS AT THE BOTTOM OF PATIENT APPROXIMATELY 30CM AWAY FROM PATIENT'S FOOT END WITH THE MONOPOLAR SETTING: COAGULATION MODE-FULGURATION:30 CUTTING MODE: BLEND:30, BIPOLAR SETTING: 15 STANDARD. CABLES WERE NOT OVER (CROSSING) THE PATIENT IN THE BURNING SITE AND NO METAL PARTS CONTACTING THE PATIENT BURNED SITE. THE BIPOLAR AND BIPOLAR CABLE USED WAS A COMPETITOR'S DEVICE. BURN WAS COVERED AS A TREATMENT. PHOTOGRAPH WAS RECEIVED AND SHOWED BLACK APPEARANCE OF THE BURN.

  Patient problems: Burn(s)

  MAUDE report 12391506 ↗
• MalfunctionOct 31, 2020Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, 2% CHLORHEXIDINE GLUCONATE AND 70% ISOPROPYL ALCOHOL + HIGH FLOW OXYGEN + COMPRESSES IN THE AREA + ELECTRO-SCALPEL, IT WAS WHAT CAUSED THE FIRE. THE PATIENT HAD A 2ND DEGREE BURN DUE TO THE ISSUE AND HAD TO STAY FOR ANOTHER ONE DAY IN THE HOSPITAL. THE BURN WAS TREATED WITH PHYSIOLOGICAL SOLUTION AND COVERED WITH A SILICONE DRESSING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10767444 ↗
• MalfunctionJul 14, 2020Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PENCIL WAS PLACED ON A VAGINAL TABLE WHICH WAS A STERILE FIELD AFTER IT HAD BEEN IN USE AND THE PENCIL CONTINUED TO GENERATE HEAT WITHOUT THE SWITCH BEING PRESSED. THE PENCIL CAUSED BURNS TO THE DRAPE AND SURGEON'S GOWN. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271526 ↗
• MalfunctionApr 9, 2020Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CHEST THORASCOPY, THE PENCIL BECAME DEFECTIVE WHEREIN THE TIP FELL OUT. ANALYSIS OF THE PHOTO PROVIDED SHOWED THAT THE TIP OF THE PENCIL WAS RE-ATTACHED. THERE WAS NO PATIENT INJURY. THERE WAS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943312 ↗
• MalfunctionOct 14, 2019Self-Activation or Keying; Inappropriate/Inadequate Shock/Stimulation; Self-Activation or Keying; Inappropriate/Inadequate Shock/Stimulation

  ACCORDING TO THE REPORTER, DURING COLONIZATION PROCEDURE, WHILE ASSEMBLING THE DEVICE TO ANOTHER ELECTRODE IT ACTIVATES ITSELF. THE INSTRUMENTALIST TRIED TO SWITCH THE TIP OF THE PENCIL TO A BALL ELECTRODE AND RECEIVED A TOUCH OF ELECTRICAL CURRENT. THEY REPLACED THE DEVICE WITH A LIKE DEVICE TO COMPLETE THE CASE.

  Patient problems: Electric Shock

  MAUDE report 9189331 ↗
• MalfunctionApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Burn(s)

  MAUDE report 8469890 ↗
• MalfunctionNov 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE BUTTON WAS NOT FUNCTIONING WELL. WHEN THE DOCTOR PRESSED IT, IT WOULD START TO BURN HIS FINGER. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 8083058 ↗