Valleylab SEP6015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521750937), received between Mar 24, 2020 and Aug 4, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Fire” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING POST OPERATIVE TONSIL AND ADENOID REMOVAL, THE PATIENT HAD POST OPERATIVE TONSIL BLEEDING HOURS AFTER THE PROCEDURE. USED A SMOKE EVACUATION PENCIL AND SUCTION COAGULATOR. NO DEVICES HAVE BEEN SAVED. BLOOD TRANSFUSION WAS NOT NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22700129 ↗
• MalfunctionJun 4, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PENCIL ACTIVATED WITHOUT PUSHING THE BUTTON. THE SURGEON STATED THAT THE PENCIL ACTIVATED ¿ON ITS OWN¿. THE ACTIVATION BUTTON OR SWITCH DID NOT STICK IN THE "ON" POSITION. THIS CAUSED SMALL ELECTROSURGICAL BURN NEAR OPERATIVE SITE AND THE DEGREE OF BURN WAS 1ST DEGREE ON THE PATIENT. THERE WAS NO TREATMENT NEEDED TO THE BURN. THE GENERATOR AND THE PENCIL WERE BOTH REPLACED TO AVOID FURTHER ISSUES AND TO COMPLETE THE PROCEDURE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19463616 ↗
• MalfunctionJan 26, 2024Device Remains Activated; Self-Activation or Keying; Device Remains Activated; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED. THE PHYSICIAN NOTED THAT THE COAG SWITCH WAS STICKING AND ACTIVATING WHEN NOT WANTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589979 ↗
• MalfunctionApr 5, 2023Peeled/Delaminated; Device Difficult to Setup or Prepare; Peeled/Delaminated; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS TELESCOPING SMOKE EVACUATION PENCIL WITH ROCKER SWITCH. THE BLADE ELECTRODE WAS DIFFICULT TO INSERT INTO THE PENCIL. MINOR SCRATCHES APPEARED TO BE ON THE INSULATED TIP. THE PENCIL WAS NOT USED FOR THE PROCEDURE. A NEW PENCIL WAS OPENED AND USED FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685715 ↗
• MalfunctionFeb 8, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING LIVER RESECTION, THERE WAS AN ACTIVATION ISSUE, THE DEVICE WAS NOT USED AT THAT TIME, IT WAS SITTING ON THE DRAPES AND HEARD THE SOUND OF THE DEVICE BEING ACTIVATED, IT TOOK A SECOND TO REALIZE WHAT WAS GOING ON, PICKED UP THE HANDPIECE AND REALIZED THE CUT FUNCTION WAS GOING, IT NEVER SEEN THAT HAPPENED AND TOUCHED THE OPEN WOULD ACTUALLY LIVE, IT STOPPED SPONTANEOUSLY AFTER OPERATING AUTONOMOUSLY FOR ABOUT 15-20 SECONDS, STOPPED THE CASE AND INSPECTED THE PATIENT TO SEE IF THE DEVICE HAD BURNED THROUGH THE DRAPE AND INTO THE PATIENTS CHEST AS THAT'S WHERE IT WAS SITTING FOR A FEW SECONDS BEFORE THEY NOTICED THE SOUND, THEY CHANGED THE DEVICE AND THE NEXT DEVICE HAD NO ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325484 ↗
• MalfunctionFeb 6, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD SELF-ACTIVATION. THE SURGEON USES COAG FOR THE WHOLE CASE. THE CUT FUNCT ION WAS ACTIVATED WHEN THEY LAID THE PENCIL DOWN. THE CUT FUNCTION WOULD STAY ON AFTER EACH USE. HELD THE PENCIL AND WATCHED IT REMAIN ON CUT WHEN NOT PUSHING BUTTON. THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED. ANOTHER HAND PIECE AS USE AND WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306023 ↗
• MalfunctionMay 16, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE EDGE BLADE ELECTRODE TIP OF THE DEVICE STARTED ON FIRE ACCORDING TO SURGICAL TECH. DID NOT SAW ANY FLAME TO CONFIRM. PHYSICIAN HAD DEVICE PLUGGED INTO A GENERATOR MONOPOLAR PORT WORKING AT 70 CUT 30 COAGULATION. SURGICAL TECH NOTICED ISSUE WHEN IN BETWEEN USE ACCESSING THE ANTERIOR HIP FOR HIP REPLACEMENT PROCEDURE. ONCE SHOWN THE TIP OF THE DEVICE, AN ESCHAR BUILD UP WAS NOTICED AS NORMAL BUT NO SMOKE OR FLAME. RECOMMENDED TO SWITCH OUR THE TIP OF THE DEVICE TO THEIR USUAL MEGADYNE TIP AND NO ISSUES NOTICED AFTER TIP SWITCH OUT. PRODUCT PERFORMED AS USUAL TO EVACUATE SMOKE PLUME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408120 ↗
• MalfunctionMay 13, 2022Fire; Device Remains Activated; Fire; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING OPEN ABDOMINOPERINEAL RESECTION, THE PENCIL WAS REMOVED FROM THE TISSUE AFTER ACTIVATION, IT WAS NOTICED THE TIP OF THE ELECTRODE HAD A FLAME ON IT WHILE NO LONGER ACTIVATING ON PATIENT TISSUE. THE MATCH-SIZE FLAME ON THE CAUTERY PENCIL ELECTRODE LEFT A WHITE COLORED AREA ON THE ELECTRODE. IT WAS UNCLEAR IF THE ISSUE WAS DUE TO THE PENCIL OR THE FT10 OR DUE TO TISSUE BUILD UP ON THE ELECTRODE. THE FACILITY¿S BIOMED INSPECTION OF THE DEVICE AND GENERATOR REVEALED THE FT10 LOGS DISPLAYED ¿STUCK BUTTON.¿ NO OPERATING ROOM FIRE NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399698 ↗
• MalfunctionAug 3, 2021Fire; Melted; Peeled/Delaminated; Fire; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING BREAST REDUCTION SURGERY, THE EDGE COATED BLADE OF THE SEP6015 CAUGHT FIRE. THE MELTED INSULATION DID NOT FALL APART AND DID NOT FALL INTO PATIENT'S CAVITY; IT SEEMED TO DISAPPEAR/VAPORIZE. NO PHYSICAL PARTS CAME OFF OF THE BLADE. THE BLADE LOOKED WHITE THE FACT THAT THE COATING CAUGHT FIRE. THIS HAPPENED WORKING WITH THE PURE CUT MODE AT 50 WATTS IN THE BREAST FATTY TISSUE. THE FLAME WAS NOT BIG AND WENT OUT PRETTY SOON. IT STARTED DURING NORMAL USE OF ELECTROSURGERY IN THE MENTIONED SETTINGS AND ENDED AFTER WAITING FOR A SMALL INSTANT AND WAVING THE PENCIL THAT CAUSED THE SMALL FLAME TO GO OUT. NO FURTHER ACTION WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266458 ↗
• MalfunctionJan 13, 2021Fire; Fire

  ACCORDING TO THE REPORTER, THE SURGEON SAW A SMALL FLAME ON THE DISTAL TIP OF THE ELECTRODE. THE PENCIL WAS BEING USED FOR 1.5 HOURS AND THE GENERATOR WAS SET TO 30/30. THERE WAS A SMALL AMOUNT OF ESCHAR ON THE CAUTERY TIP. ADDITIONAL ESCHAR MAY HAVE BURNED OFF. ANOTHER PENCIL WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT FURTHER TROUBLE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167175 ↗
• MalfunctionOct 31, 2020Overheating 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, DURING THE PROCEDURE, THE PRODUCT WAS REPORTED TO REQUIRE A HIGHER SETTING TO GET THE BEST RESULT IN CAUTERIZATION AND THE TIP STAY HEATED LONGER THAT IT HAD BURNT DRAPES, GOWNS AND SKIN BARRIERS UPON CONTACT FOR QUICK SECONDS. THERE WERE INSTANCES WHEN IT PENETRATED THROUGH THE SKIN BARRIERS SUCH AS IOBAN WHICH RESULTED TO A TINY BURN ON THE PATIENT'S SKIN. AN ERS (ERYTHROCYTE SEDIMENTATION RATE) WAS DONE FOR THIS.

  Patient problems: Burn(s)

  MAUDE report 10767242 ↗
• MalfunctionMar 24, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PENCIL TIP CAUGHT ON FIRE AT THE END OF THE CASE. FIRE WAS EXTINGUISHED BEFORE IT SPREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876190 ↗