Valleylab SEP5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521750593), received between Apr 16, 2019 and Dec 27, 2024 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 A SMALL 3 TO 4MM IN SIZE BURN AND NO BLISTERS. LEFT A SMALL WHITE MARK TO THE SURGEON'S MIDDLE OF INDEX FINGER. THE SURGEON WAS USING THE PENCIL ON TISSUE AND HOLDING IT WITH HIS FINGER UNDERNEATH THE SITE WHICH HE WAS BURNING. THE NURSE REPORTED THAT THE SURGEON STATED THAT HE HAS BEEN USING THIS PRACTICE AS LONG AS HE HAS BEEN PRACTICING. NO TREATMENT DONE TO BURN SITE. THE PATIENT WAS NOT INJURED.

  Patient problems: Burn(s)

  MAUDE report 21028666 ↗
• MalfunctionNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL MASTECTOMY PROCEDURE, THE SURGEON HELD THE DEBAKEY FORCEPS WHILE THEY "BUZZED" THE ES PENCIL ON THE FORCEPS TO STOP A SMALL BLEED. THEY BUZZED THE DEBAKEY FORCEPS BELOW THE SURGEON'S HAND CLOSER TO THE PATIENT'S AND IT TRANSFERRED ENERGY TO THE SURGEON'S FINGER. THE SURGEON'S GLOVE SHOWED A MATCH FLAME SIZE, AND THE SURGEON'S GLOVE AND HAND WERE SUBSEQUENTLY BURNED. THEY STAMPED OUT TO EXTINGUISHED THE FIRE AND THE SURGICAL FIELD WAS WET. THE SURGEON HAD A 2ND DEGREE BURN AT THE INDEX FINGER.

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding; Partial thickness (Second Degree) Burn

  MAUDE report 20706507 ↗
• MalfunctionAug 15, 2024Suction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Suction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO REPORTER, DURING PROCEDURE, OR STAFF UNNECESSARILY EXPOSED TO CAUTERY SMOKE AND PATIENT DUE TO POOR QUALITY CAUTERY PENCIL. COVIDIAN CAUTERY PENCILS LACK A PROTECTIVE SHEATH FOR THE CAUTERY TIP, EXPOSING PATIENTS TO BURN INJURIES AND HAVE INSUFFICIENT SMOKE EVACUATION, EVEN AT 100% EXPOSING STAFF TO CARCINOGENS IN THE OR. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 19992188 ↗
• MalfunctionAug 15, 2024Suction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Suction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO REPORTER, DURING PROCEDURE, OR STAFF UNNECESSARILY EXPOSED TO CAUTERY SMOKE AND PATIENT DUE TO POOR QUALITY CAUTERY PENCIL. COVIDIAN CAUTERY PENCILS LACK A PROTECTIVE SHEATH FOR THE CAUTERY TIP, EXPOSING PATIENTS TO BURN INJURIES AND HAVE INSUFFICIENT SMOKE EVACUATION, EVEN AT 100% EXPOSING STAFF TO CARCINOGENS IN THE OR. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 19991958 ↗
• MalfunctionAug 15, 2024Suction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Suction Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO REPORTER, DURING PROCEDURE, OR STAFF UNNECESSARILY EXPOSED TO CAUTERY SMOKE AND PATIENT DUE TO POOR QUALITY CAUTERY PENCIL. COVIDIAN CAUTERY PENCILS LACK A PROTECTIVE SHEATH FOR THE CAUTERY TIP, EXPOSING PATIENTS TO BURN INJURIES AND HAVE INSUFFICIENT SMOKE EVACUATION, EVEN AT 100% EXPOSING STAFF TO CARCINOGENS IN THE OR. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 19991814 ↗
• InjuryJan 12, 2024Self-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 LEG VEIN HARVESTING, THE CAUTERY PENCIL WAS LAYING AGAINST PATIENT'S LEG DURING VEIN HARVESTING. SUDDENLY ACTIVATED ON ITS OWN WITHOUT BEING PRESSED AND BEGAN TO BURN PATIENT'S LEG. ACTIVATION BUTTON OR SWITCH STICK IN WAS NOT IN "ON" POSITION. THE PENCIL WAS SWITCHED OUT, THE NEW PENCIL DID NOT MALFUNCTION IN THE SAME WAY. THE PATIENT SUSTAINED TWO BURNS LOCATED AT THE INNER LOWER LEFT LEG AND DORSAL LEFT LOWER LEG. ONE FULL THICKNESS TO THE OPERATIVE LEG THAT WAS EXCISED AND CLOSED PRIMARILY AND ANOTHER THAT WAS PARTIAL THICKNESS THAT WAS LEFT OPEN TO AIR. THE WOUNDS WERE CLOSED PRIMARILY AND WOUND CARE PROVIDED ON THE UNIT. IT DID NOT APPEAR THAT THE WOUNDS DETERIORATED DURING THAT TIME WHICH REQUIRED ESCALATION TO WOUND CARE SPECIALISTS OR ID. FURTHERMORE, ALL PT GOALS THAT WERE SET DURING THE PATIENT'S ADMISSION WERE ACHIEVED AND THE PATIENT DID NOT REQUIRE HOME CARE FOR WOUND CARE SERVICES POST-DISCHARGE.

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

  MAUDE report 18505243 ↗
• MalfunctionNov 27, 2023Fire; Fire

  ACCORDING TO THE REPORTER, THE SMOKE EVAC PENCIL ISSUE THAT CAUSED A FLAME.

  Patient problems: Insufficient Information

  MAUDE report 18213088 ↗
• MalfunctionNov 22, 2023Fire; Fire

  ACCORDING TO THE REPORTER, THE SMOKE EVAC PENCIL ISSUE THAT CAUSED A FLAME.

  Patient problems: Insufficient Information

  MAUDE report 18192311 ↗
• MalfunctionNov 22, 2023Fire; Fire

  ACCORDING TO THE REPORTER, THE SMOKE EVAC PENCIL ISSUE THAT CAUSED A FLAME.

  Patient problems: Insufficient Information

  MAUDE report 18192292 ↗
• MalfunctionOct 25, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WOULD NOT SHUT OFF WHEN THE ACTIVATION BUTTON WAS RELEASED. BUTTON RETURNED TO ITS ORIGINAL POSITION. THE DEVICE WAS UNPLUGGED FROM THE GENERATOR AND PLUGGED BACK IN. AFTER THAT, IT FUNCTIONED AS EXPECTED AND WAS USED WITHOUT INCIDENT FOR THE REMAINDER OF THE CASE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004885 ↗
• MalfunctionAug 24, 2023Self-Activation or Keying; Arcing; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS PLUGGED IN BEGAN FLASHING ON THE UNIT AND SPARKED SPONTANEOUSLY RESULTING IN A SKIN BURN TO THE PATIENTS ABDOMEN. NO ONE WAS TOUCHING THE DEVICE OR THE SWITCH AT THE TIME IT SPARKED. REQUIRED TOPICAL BURN CREAM AND PRESSURE DRESSING. SUSTAINED A 1CM, 1ST DEGREE BURN. THERE WAS ALSO A PHOTO ATTACHED TO PROVED THE ALLEGATION ON THE DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17611045 ↗
• MalfunctionJul 6, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS PLUGGED INTO MONO POLAR 1 PORT ON FT10 AND ALARMED WITH A RED NOTICE STATING PROBE WAS NOT RECOGNIZED. NURSE MOVED IT TO MONO POLAR 2 AND A YELLOW SCREEN APPEARED AND PENCIL ACTIVATED ON ITS OWN IN THE HOLSTER. PENCIL WAS REMOVED AND REPLACED WITH CVPLP2000 AND WORKED TO GOOD EFFECT. WHEN THE ERROR LOGS WERE CHECKED TODAY IT¿S STATES MONO 1 HAND SWITCH STUCK AND THEN MONO 2 HAND SWITCH STUCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265555 ↗
• MalfunctionJun 22, 2023Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING SETUP FOR A VASECTOMY PROCEDURE, THE SURGEON LAID THE DEVICE ON THE DRAPE AND IT BURNED (SIZE OF THE TIP OF THE PENCIL TIP) THE PATIENT'S LEG. IT ACTIVATED WITH NO ONE TOUCHING IT AS SOON AS IT WAS CONNECTED TO THE GENERATOR AS IT MADE A NOISE AS IF THE PENCIL WAS STILL ACTIVATED THEN IT WAS DISCONNECTED. THERE WAS NO OPERATING ROOM FIRE, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED AND IT DID NOT LEAD TO PROLONGED HOSPITALIZATION.

  Patient problems: Burn(s)

  MAUDE report 17185893 ↗
• MalfunctionApr 25, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS ACTIVATED EVEN WHEN BUTTON WAS NOT PRESSED, IT WAS ON THE WHOLE TIME. A NEW DEVICE WAS USED, THERE WAS NO ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809067 ↗
• MalfunctionMar 14, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PENCIL ACTIVATED WHEN PLUGGED IN TO AN FT10 WITHOUT ANYONE PRESSING THE BUTTON OR STEPPING ON THE FOOT PEDAL. THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED AND THE ACTIVATION BUTTON DID NOT STICK IN THE ON POSITION. THE GENERATOR USED ALONG WITH THE HANDPIECE WAS WORKING INTERMITTENTLY. ANOTHER PENCIL WAS USED, HOWEVER, IT HAD THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542355 ↗
• MalfunctionSep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT MISFIRED AND BURNED THE PATIENT'S LEG WHEN THE PENCIL WAS LAID ON THE OPERATING ROOM TABLE BETWEEN THE PATIENT'S LEG AND THE UNIT.

  Patient problems: Burn(s)

  MAUDE report 15432406 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THE LEEP (LOOP ELECTROSURGICAL EXCISIONS PROCEDURE) CONE, THE DEVICE STOPPED WORKING, AND SUTURING WAS REQUIRED TO STOP THE BLEEDING BECAUSE THE SURGEON COULDN¿T FINISH THE CASE WITH CAUTERY. THERE WAS MORE THAN 500 CC OF BLOOD LOSS AND THE EVENT LED TO A 1 DAY EXTENSION OF PATIENT'S HOSPITALIZATION.

  Patient problems: Blood Loss

  MAUDE report 8699928 ↗
• InjuryJun 14, 2019Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING EXCISION CERVICAL LEEP, THE DEVICE STOPPED WORKING DURING CRITICAL ACTIVATION PHASE WHEN CERVICAL CONE BIOPSY WAS PARTIALLY REMOVED FROM THE CERVIX, UNABLE TO ACTIVATE PENCIL AGAIN WHICH RESULTED IN EXCESSIVE AMOUNT OF 800 CC BLOOD LOSS. SUTURING WAS DONE TO COMPLETE THE CASE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8699770 ↗
• MalfunctionJun 13, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING MASTECTOMY, WHEN THE SURGEON STARTED ON THE SECOND BREAST AND WAS TRYING TO BURN ON A PINCETT, A SMALL FLAMES WAS SEEN ON THE TOP OF THE ELECTRODE. THE DEVICE WAS TOOK OUT AND A TOWEL WAS USED TO EXTINGUISHED THE FLAME. THE DEVICE WAS REPLACED WITH A NEW ONE AND WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696788 ↗
• MalfunctionApr 16, 2019Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, SURGEON HAD MINOR BURN ON THE HAND CAUSED BY SPARKING OF THE PENCIL USED.

  Patient problems: Burn(s)

  MAUDE report 8519686 ↗