Valleylab E2516HRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884524000053), received between Jun 8, 2018 and Aug 4, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Fire” (11 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50129143 ↗
• MalfunctionApr 21, 2025Self-Activation or Keying; Failure to Cut; Self-Activation or Keying; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LEFT PULMONARY BULLAE RESECTION, THORACOSCOPIC PLEURAL REPAIR, AND THORACOSCOPIC PLEURODESIS UNDER GENERAL ANESTHESIA WITH TRACHEAL INTUBATION, AFTER THE ELECTROSURGICAL GENERATOR WAS CONNECTED TO THE HOST, THE "ELECTROCUT" KEY CONTINUED TO WORK AND THE HEAD OF THE ELECTROSURGICAL GENERATOR TURNED BLACK, AND THE WORK COULD NOT BE CANCELED UNTIL THE ELECTROSURGICAL PENCIL WAS SEPARATED FROM THE HOST. THE SELF-ACTIVATION HAPPENED WITHOUT PRESSING/PUSHING OF ACTIVATION BUTTON. REPLACING THE ELECTROSURGICAL GENERATOR MACHINE COULD NOT SOLVE THE PROBLEM, AND IT COULD BE USED NORMALLY AFTER REPLACING THE ELECTROSURGICAL INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 21873743 ↗
• MalfunctionJan 15, 2025Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOVIE PENCIL WAS MISFIRING WHEN NOT BEING ACTIVATED, CAUSING A BURN TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 21160482 ↗
• MalfunctionJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY AND ADENOIDECTOMY, A SECOND DEGREE BURN ON THE SIDE FACE OF THE PATIENT WAS CAUSED BY A PART OF PENCIL THAT SHOULD NOT HAVE BURNED ANYTHING - INSULATION WAS INTACT ON THE ELECTRODE. THE BURN WAS PEA TO DIME SIZED. ANTACID, LIDOCAINE, ANTIHISTAMINE, TOPICAL MUPIROCIN ANTIBIOTIC OINTMENT AND VASELINE WAS GIVEN TO PATIENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19842472 ↗
• MalfunctionApr 25, 2024Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PENCIL WAS PLACED ON FORCEP FOR 1 - 2 SECOND/S AND MATCHED SIZE FLAME HAPPENED. IT WENT OUT ON ITS OWN QUICKLY. STATED CLEAN TIP. THE PENCIL SPARKED BUT NO BURNS. NO OPERATING ROOM FIRE HAPPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181533 ↗
• MalfunctionFeb 1, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING USE OF THE OPERATING ROOM TEACHER, THE DEVICE¿S INSULATION SKIN WAS RUPTURED.

  Patient problems: Insufficient Information

  MAUDE report 18623455 ↗
• InjuryJan 19, 2024Break; Delivered as Unsterile Product; Peeled/Delaminated; Detachment of Device or Device Component; Break; Delivered as Unsterile Product; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD PACKAGING ISSUE, THE BLUE PART GOT BROKEN, PEELED ONLY, AND THERE WAS A DAMAGE TO INNER PLASTIC TRAY. STERILITY WAS COMPROMISED. A PIECE FELL INTO PATIENT CAVITY AND WAS FULLY RETRIEVED, NO X-RAY WAS REQUIRED TO ASSIST IN LOCATING THE PIECE. ADDITIONAL MEDICAL PROCEDURE WITH A REGULAR INSTRUMENT WAS NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THE DEVICE WAS REMOVED IN THE PRIMARY PROCEDURE. THE PROCEDURE WAS COMPLETED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547490 ↗
• MalfunctionDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Localized Skin Lesion; Skin Discoloration; Superficial (First Degree) Burn

  MAUDE report 18278666 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAMINECTOMY, A CLEAR PIECE CAME OFF OF THE CAUTERY TIP AND RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145813 ↗
• MalfunctionAug 11, 2023Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WERE SPARKING WHEN THE ELECTRODE TOUCHED THE FORCEPS. THERE WAS NO OPERATING ROOM FIRE AND WAS EXTINGUISHED ON ITS OWN. THE SAME PENCIL WAS USED FOR THE REMAINDER OF THE CASE WITH NO ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510303 ↗
• MalfunctionAug 4, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS SELF ACTIVATING. OTHER PENCIL WORKED NORMALLY. THERE WAS NO PATIENT INVOLVE MENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463936 ↗
• MalfunctionFeb 17, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING ABDOMINAL PROCEDURE, THE PENCIL AUTOMATICALLY TURNED ON THE CUT SETTING EVEN WHEN NOT TRIGGERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396431 ↗
• MalfunctionSep 16, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE DEVICE CAUGHT ON FIRE, THE TIP WAS NOT INSIDE THE PATIENT WHEN THE FLAME OCCURRED. THE TISSUE WAS CLAMPED WITH A STILLE CLAMP, THE CAUTERY WAS ABOVE THE SKIN TOUCHING THE CLAMP TO CAUTERIZE TISSUE WHEN THE NURSE NOTICED THE TIP BEGAN SMOKING AND STARTED SPARKING AND THEN CAUGHT FIRE. THE FLAME WAS ABOUT MATCH SIZE IT BURNED FOR 5 SECONDS, SHE FANNED THE FLAME OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442566 ↗
• MalfunctionDec 7, 2021Inappropriate/Inadequate Shock/Stimulation; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD ACTIVATION ISSUE. THE BOVIE WAS USED BY THE DOCTOR, WHO WAS SHOCKED AND UNABLE TO SWITCH IT BACK ON. THE HANDPIECE DID NOT TURN ON WHEN THE CIRCULATING NURSE REPLACED THE MACHINE PORTS. BEFORE THEY USED A NEW HANDPIECE, THEY DOUBLE-CHECKED TO MAKE SURE THE GROUNDING PAD WAS PLACED TO THE PATIENT'S BODY AND PLUGGED IN. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH A NEW HANDPIECE. THE SURGICAL FIELD WAS DRY, BUT THE SURGEON SUFFERED A SMALL BURN ON HER THUMB AND FELT LIGHT-HEADED AND DIZZY AFTERWARD. THEY DO NOT HAVE THE SIZE OF THE BURN. THEY STATED THAT IT WAS A SMALL BURN. THE DOCTOR DECLINED TREATMENT AND EVALUATION AT THE TIME OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s); Dizziness; Electric Shock

  MAUDE report 12951347 ↗
• MalfunctionOct 5, 2021Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING HEPATECTOMY SURGERY, THE INSULATION ON THE BOVIE TIP FELL APART OR WAS BREAKING APART AND THE SURGEON WAS AWARE. HOWEVER, SINCE THERE WERE 2 BOVIE PENCILS USED DURING THE SURGERY (1 CAME FROM PACK, 1 CAME AS INDIVIDUALLY PACK) WHICH LOOKED SIMILAR, THE SCRUB TECH WAS NOT ABLE TO DISTINGUISH WHICH ONE CAME FROM PACK AND WHICH ONE IS THE PEEL PACK BUT BOTH PACKAGING WERE SAVED. THE SURGICAL TIP WAS REMOVED AND CHANGED INTO A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577756 ↗
• MalfunctionMar 4, 2021Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE SPARKED ON A FACE CHEEK AND CAUGHT A COTTON BALL IN THE PATIENTS LEFT EAR ON FIRE. FIRE WAS QUICKLY PUT OUT, PATIENT'S OUTSIDE OF EAR WAS RED AT THE END OF THE PROCEDURE AND ANTIBIOTIC OINTMENT WAS PUT ON IT. THE DEGREE AND SIZE OF THE BURN WAS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 11411927 ↗
• MalfunctionFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RADICAL MASTECTOMY PROCEDURE FOR LEFT BREAST CANCER, THERE WERE BLACK DOTS ON THE PATIENT ADHESIVE SURFACE. THE PENCIL IGNITED THE GAUZE BUT NO BURN CAUSED TO PATIENT. THE FIRE WAS EXTINGUISHED BY COVERING IT WITH A DRAPE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333930 ↗
• MalfunctionDec 10, 2020Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS ARCING/SPARKING. THE SKIN HAD FIRST DEGREE BURN, REDNESS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10988543 ↗
• MalfunctionOct 21, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CUTTING DOWN INTO THE FAT OF THE PATIENT, A SMALL FLAME APPEARED AT THE TIP OF THE DEVICE. IT WAS DOUSED WITH WATER TO PUT IT OUT. A NEW PENCIL WAS OPENED WITH THE SAME GENERATOR IN USE AND THE CASE CONTINUED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10710692 ↗
• MalfunctionApr 21, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A WHIPPLE PROCEDURE, A FLAME ARCED FROM THE BOVIE PENCIL TIP LIGHTING ON FIRE. THE DOCTOR SHOOK THE BOVIE AND THE FLAME WENT OUT IMMEDIATELY. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9982559 ↗
• MalfunctionDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT 1520, WHILE THE RESIDENT WAS RETRACTING THE TISSUE AND THE SURGEON WAS UTILIZING THE PENCIL, A NON-MEDTRONIC GAUZE IN THE RESIDENT'S HAND HEATED UP, SMOKED AND CAUGHT ON FIRE. THE RESIDENT PULLED THE NON-MEDTRONIC GAUZE AWAY FROM THE PATIENT AND NOTICED THAT IT WAS INDEED SMOKING. HE BROUGHT THE NON-MEDTRONIC GAUZE FURTHER FROM THE DRAPES TOWARDS THE FOOT OF THE BED AND INFORMED THE CIRCULATION NURSE. THE NURSE TOLD THE RESIDENT TO DROP THE FLAMING NON-MEDTRONIC GAUZE ON A CLEAR AREA ON THE FLOOR. THE NURSE SCRUBBED OUT TO PUT OUT THE FIRE USING THE SALINE ON HER FIELD WITH AN ASEPTO BULB SYRINGE. AFTER INFORMING THE RESOURCE NURSE, THE PATIENT WAS ASSESSED FOR BURNS. THE ATTENDING, RESIDENT AND NURSE CHECKED THE SKIN BEFORE APPLYING DRESSINGS BUT THE SKIN WAS FREE FROM ANY INJURY OR BURNS AT 1607. THE RETURN ELECTRODE MANAGEMENT (REM) PAD WAS REMOVED AT 1613 A ND THE SITE WAS CLEAR AND INTACT. IT WAS NOTED THAT THE SURGEON AND RESIDENT WERE UTILIZING THE PENCIL PROPERLY AND IT WAS NOT IN DIRECT CONTACT WITH THE NON-MEDTRONIC SPONGE THAT CAUGHT FIRE. THE RESIDENT WAS HOLDING THE NON-MEDTRONIC GAUZE WITH THE SAME HAND THAT WAS USED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9436973 ↗
• MalfunctionNov 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE COMPLETELY FELL APART UPON OPENING OF THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9293976 ↗
• MalfunctionAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE BUNION SURGERY, THE GENERATOR HAD NO SOUND, WHILE THE CAUTERY PEN CAUSED BURN IN THE PATIENT'S LEFT CALF AREA. SUTURE WAS USED TO CLOSE THE BURN SITE / WOUND.

  Patient problems: Burn(s); No Code Available

  MAUDE report 8905601 ↗
• MalfunctionMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, THE PATIENT WAS BURNED WITH THE CAUTERY DEVICE.

  Patient problems: Burn(s)

  MAUDE report 8405507 ↗
• MalfunctionFeb 21, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING EXCISION SOFT TISSUE MASS ON BACK AND ON FOREARMS, THE DOCTOR HAD COMPLETED THE EXCISION OF SOFT TISSUE MASS ON THE BACK AND MOVED TO THE FOREARM. THE DOCTOR MADE THE INCISION AND THEN USED THE CAUTERY PENCIL TO CAUTERIZE THE BLEEDING. AS THE DOCTOR WAS MOVING TO LAY THE PENCIL DOWN, THE TIP CAUGHT ON FIRE. THE DOCTOR IMMEDIATELY IMMERSED THE PENCIL IN THE BASIN OF FLUID ON THE STERILE FIELD. HANDPIECES AND THE GENERATOR WERE REMOVED FROM THE OPERATING ROOM AND REPLACED WITH DIFFERENT GENERATOR AND NEW DISPOSABLES. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357988 ↗