Valleylab SEP6000Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10884521750913), received between Mar 19, 2019 and Mar 13, 2026 — classified as 9 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (46 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 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Self-Activation or Keying; Failure to Cut

  IT WAS REPORTED THAT PRIOR TO AN OPEN ORTHO PROCEDURE, THE PENCIL WAS PLUGGED IN AND WAS ACTING AS IF IT WERE BEING ACTIVATED DESPITE NO ONE PUSHING ANY BUTTONS. THE ESU (ELECTRO SURGICAL UNIT) MADE THE ERROR INDICATING NO REM PAD WITH THE "CUT" ICON ON THE ESU SCREEN HIGHLIGHTING YELLOW AS IF SOMEONE WERE ACTIVATING THE PENCIL. THE STAFF THEN UNPLUGGED AND PLUGGED THE PENCIL BACK IN AND THE PENCIL CONTINUED TO ACT AS IF IT WERE BEING ACTIVATED. THE STAFF PUT THIS PENCIL OFF TO THE SIDE AND GRABBED A NEW PENCIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591384 ↗
• MalfunctionDec 22, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLASTIC SURGERY, AN ELECTRODE MOUNTED ON THE SMOKE PENCIL WAS USED. THE ELECTRODE WAS APPLIED TO ACTIVATE A FORCEPS ON A BLOOD VESSEL, WHICH IS UNDERSTOOD TO BE STANDARD SURGICAL PRACTICE. DURING THIS USE, THE INSULATION COATING ON THE BLADE FAILED. THE COATING DEGRADED AND MELTED OFF WHILE THE DEVICE WAS BEING ACTIVATED. THE MELTED PIECE DID NOT FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863885 ↗
• MalfunctionSep 18, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DIATHERMY PEN ACTIVATED DESPITE NOT PUSHING ANY BUTTONS ON THE PEN UPON PLUGGING IN THE MONOPOLAR CABLE. THIS HAPPENED AGAIN EVEN WHEN PLUGGED INTO A DIFFERENT OUTLET. A NEW HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088434 ↗
• MalfunctionJun 26, 2025Fire; Intermittent Energy Output; Fire; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A TOTAL HYSTERECTOMY AND BILATERAL SALPINGO OOPHORECTOMY, A FLAME APPEARED AT THE TIP OF THE DIATHERMY PENCIL ABOUT THE LENGTH OF A PEN. IT HAD TO BE WAVED ABOUT AND BLOWN ON TO BE PUT OUT. THE SURGEON HAD ALREADY USED THE DIATHERMY HANDPIECE FOR A SHORT PERIOD WITH NO ISSUE, BUT ON USING IT AGAIN, A SMALL FLAME APPEARED AT THE TIP. THE HAND PIECE WAS REMOVED FROM THE SURGICAL SITE, A NEW ONE WAS OPENED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337394 ↗
• MalfunctionJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON WAS HOLDING THE FORCEPS IN HIS HAND PINCHING TISSUE AND WHEN THE NURSE ENGAGED THE UNIT ON THE FORCEPS, IT BURNED THE SURGEON'S FINGER. THE BURN WAS A VERY SMALL RED DOT.

  Patient problems: Burn(s)

  MAUDE report 22141868 ↗
• MalfunctionJun 2, 2025Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR DEVICES EXPERIENCED SELF-ACTIVATION WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED DURING PROCEDURE, SPECIFICALLY THE CUT MODE (YELLOW BUTTON) ACTIVATED ITSELF AND RESULTED IN A SMALLER THAN 1 CM FIRST DEGREE BURN ON THE PATIENT'S ARM WHILE COAG MODE DID NOT ACTIVATE AT ALL. THE BURN WAS COLD WRAPPED FOR A FEW MINUTES. THE PATIENT SUSTAINED A TEMPORARY INJURY FROM THE BURN BUT RECOVERED WELL. OTHER PENCILS WORKED FINE WITH THE SAME GENERATOR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22124431 ↗
• MalfunctionJun 2, 2025Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR DEVICES EXPERIENCED SELF-ACTIVATION WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED DURING PROCEDURE, SPECIFICALLY THE CUT MODE (YELLOW BUTTON) ACTIVATED ITSELF AND RESULTED IN A SMALLER THAN 1 CM FIRST DEGREE BURN ON THE PATIENT'S ARM WHILE COAG MODE DID NOT ACTIVATE AT ALL. THE BURN WAS COLD WRAPPED FOR A FEW MINUTES. THE PATIENT SUSTAINED A TEMPORARY INJURY FROM THE BURN BUT RECOVERED WELL. OTHER PENCILS WORKED FINE WITH THE SAME GENERATOR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22123925 ↗
• MalfunctionJun 2, 2025Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR DEVICES EXPERIENCED SELF-ACTIVATION WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED DURING PROCEDURE, SPECIFICALLY THE CUT MODE (YELLOW BUTTON) ACTIVATED ITSELF AND RESULTED IN A SMALLER THAN 1 CM FIRST DEGREE BURN ON THE PATIENT'S ARM WHILE COAG MODE DID NOT ACTIVATE AT ALL. THE BURN WAS COLD WRAPPED FOR A FEW MINUTES. THE PATIENT SUSTAINED A TEMPORARY INJURY FROM THE BURN BUT RECOVERED WELL. OTHER PENCILS WORKED FINE WITH THE SAME GENERATOR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22123883 ↗
• MalfunctionJun 2, 2025Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Self-Activation or Keying; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR DEVICES EXPERIENCED SELF-ACTIVATION WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED DURING PROCEDURE, SPECIFICALLY THE CUT MODE (YELLOW BUTTON) ACTIVATED ITSELF AND RESULTED IN A SMALLER THAN 1 CM FIRST DEGREE BURN ON THE PATIENT'S ARM WHILE COAG MODE DID NOT ACTIVATE AT ALL. THE BURN WAS COLD WRAPPED FOR A FEW MINUTES. THE PATIENT SUSTAINED A TEMPORARY INJURY FROM THE BURN BUT RECOVERED WELL. OTHER PENCILS WORKED FINE WITH THE SAME GENERATOR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22122411 ↗
• MalfunctionMay 29, 2025Self-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 LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN USING THE LAPAROSCOPIC CAUTERY FOOT PEDAL, LAPAROSCOPIC CAUTERY AND HANDHELD CAUTERY WERE BOTH FIRING WITHOUT US KNOWING AND HAND HELD CAUTERY BURNED A HOLE THROUGH THE DRAPE. IT WAS NOT IN ITS CAUTERY HOLDER AT THE TIME. THE FIRE WAS ABOUT THE SIZE OF A MATCH FLAME AND PUT OUT WITH SUFFOCATION. LAPAROSCOPIC CAUTERY WAS PULLED INTO CHANNEL ONE AND WE VERIFIED THAT THE FOOT PEDAL WAS CONNECTED TO CHANNEL ONE, THE HAND HELD CAUTERY WAS IN CHANNEL TWO. THE PEDAL IS THE ONE THAT IS STANDARD ON THE GENERATOR. THE GENERATOR HAS BEEN SUCCESSFULLY USED SINCE THIS INCIDENT WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110395 ↗
• MalfunctionFeb 13, 2025Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PENCIL STARTED AUTO-ACTIVATING ON ITS OWN ON THE STERILE TROLLEY WITHOUT PRESSING THE BUTTON. ANOTHER PENCIL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379027 ↗
• MalfunctionDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PENCIL HAD CAUSE SMALL BURN TO THE SURGEON'S INDEX FINGER. USING THE PENCIL AND HELD FINGER UNDERNEATH TISSUE HE WAS BURNING. HAS DONE THIS FOR AS LONG AS HE HAS BEEN A SURGEON. THE PATIENT WAS NOT INJURED.

  Patient problems: Burn(s)

  MAUDE report 21028767 ↗
• MalfunctionDec 10, 2024Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICES HAD NO COAGULATION. BLUE BUTTON WAS MALFUNCTIONING. THERE WAS NO TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS. NEW DEVICES WERE USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 20894537 ↗
• MalfunctionDec 10, 2024Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICES HAD NO COAGULATION AND NO CUTTING ISSUE. BLUE AND YELLOW BUTTONS WERE MALFUNCTIONING. THIS CAUSED TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 20894179 ↗
• MalfunctionDec 10, 2024Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICES HAD NO COAGULATION. BLUE BUTTON WAS MALFUNCTIONING. NEW DEVICES WERE USED AND IT WORKED FINE. THERE WAS NO TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 20894070 ↗
• MalfunctionDec 10, 2024Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICES HAD NO COAGULATION AND NO CUTTING ISSUE. BLUE AND YELLOW BUTTONS WERE MALFU NCTIONING. THIS CAUSED TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 20893976 ↗
• MalfunctionNov 27, 2024Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE AND HAD COAGULATION BUTTON WAS NOT WORKING. THERE WAS INS UFFICIENT/NO COAGULATION. USED ANOTHER DEVICE WHICH WORKED WELL. PATIENT HAD BLEEDING. THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR REOPERATION DONE TO PATIENT TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20798407 ↗
• MalfunctionOct 18, 2024Suction Problem; Difficult or Delayed Activation; Electrical Shorting; Suction Problem; Difficult or Delayed Activation; Electrical Shorting

  ACCORDING TO THE PROCEDURE DURING PROCEDURE, THE MONOPOLAR PENCIL WITH SMOKE EVACUATION HAD ELECTRICAL CURRENT AND SMOKE ASPIRATION WAS WORKING INTERMITTENTLY. ANOTHER DEVICE WITH ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481021 ↗
• MalfunctionOct 8, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BUTTONS WOULD 'STICK'. TRIED OTHER LOT NUMBERS AND HAD NO FURTHER ISSUES.

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

  MAUDE report 20399755 ↗
• MalfunctionOct 8, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BUTTONS WOULD 'STICK'. TRIED OTHER LOT NUMBERS AND HAD NO FURTHER ISSUES.

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

  MAUDE report 20399298 ↗
• MalfunctionOct 8, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BUTTONS WOULD 'STICK'. TRIED OTHER LOT NUMBERS AND HAD NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20397811 ↗
• MalfunctionOct 8, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BUTTONS WOULD 'STICK'. TRIED OTHER LOT NUMBERS AND HAD NO FURTHER ISSUES.

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

  MAUDE report 20397398 ↗
• MalfunctionOct 8, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BUTTONS WOULD 'STICK'. TRIED OTHER LOT NUMBERS AND HAD NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20397126 ↗
• MalfunctionOct 3, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING OVARIAN RESECTION WITH RADICAL DISSECTION FOR DEBULKING CYSTOTOMY FOR EXCISION OF BLADDER TUMOR AP PENDECTOMY, THE PENCIL TURNED ON MULTIPLE TIMES FOR EXTENDED PERIODS OF TIME WITHOUT ANYONE TOUCHING IT. PATIENT WAS DISCHARGE.

  Patient problems: Insufficient Information

  MAUDE report 20363001 ↗
• MalfunctionSep 16, 2024

  THE SURGICAL PENCIL TURNED ON MULTIPLE TIMES FOR EXTENDED PERIODS OF TIME WITHOUT ANYONE TOUCHING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224704 ↗