Valleylab E2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 20884524001590), received between Jul 13, 2017 and Sep 30, 2026 — classified as 6 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (13 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Self-Activation or Keying

  Patient problems: Insufficient Information

  MAUDE report 50950996 ↗
• MalfunctionMay 20, 2026Device Remains Activated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BREAST-CONSERVING SURGERY FOR BREAST CANCER, THE BUTTON ON THE DEVICE DID NOT RECOIL AUTOMATICALLY, CAUSING A SKIN BURN OF 1.0 CM X 1.0 CM ON THE PATIENT'S LEFT UPPER ARM. WHEN THE CONDITION WAS DISCOVERED, THE PENCIL WAS IMMEDIATELY DISCONTINUED AND THE CABLE WAS DISCONNECTED. THE AFFECTED AREA WAS WETTED AND THE PATIENT WAS DISINFECTED.

  Patient problems: Burn(s)

  MAUDE report 25230605 ↗
• InjuryFeb 23, 2026Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE CAUTERY WAS NOT ACTIVATING AND WAS MISFIRING AT THE START OF THE CASE. ALL CONNECTIONS WERE CHECKED BY THE CIRCULATOR AND SCRUB NURSE. THE SURGEON WAS ADVISED TO CHECK THE CAUTERY TIP CONNECTION, AND IN RESPONSE, REMOVED AND REINSERTED THE TIP. THE PATIENT UNDERWENT SURGERY, AND ONCE THE DAVIS-BOYLE GAG WAS RELEASED, THE SURGEON IDENTIFIED SIGNIFICANT PARTIAL TO FULL-THICKNESS BURNS TO THE BILATERAL CORNERS OF THE PATIENT¿S MOUTH THAT HAD OCCURRED DURING THE PROCEDURE. THE SURGEON IMMEDIATELY APPLIED SALINE SOAKED GAUZE TO THE AREA. PLASTIC SURGERY WAS NOTIFIED, AND A STAFF CAME TO THE ROOM TO EXAMINE THE AREA AND WILL FOLLOW THE PATIENT. THE PLASTIC SURGERY TEAM COMPLETED AN ASSESSMENT, TOOK PHOTOGRAPHS, AND RECOMMENDED ADMISSION OF THE PATIENT. THE SITE WAS CLEANSED WITH STERILE NS, DRIED, AND POLYPORE OINTMENT WAS APPLIED TO THE AFFECTED AREAS BY THE ENT SURGEON. THE PATIENT REQUIRED ADDITIONAL ANESTHESIA TIME.

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

  MAUDE report 24413818 ↗
• MalfunctionAug 6, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PROCEDURE, THE MONOPOLAR SCALPEL TRIGGERED ON ITS OWN WITHOUT PRESSING ANY OF THE BUTTONS ON THE HAND SWITCH WHILE IT WAS PLACED ON THE OPERATING FIELD. THERE WAS NO OTHER HANDPIECE USED WITH THE SAME GENERATOR THAT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724203 ↗
• MalfunctionApr 17, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING SCALP LIPOMA EXERESIS SURGERY, THE ELECTRIC SCALPEL PEN HAD A TECHNICAL DEFECT (SPARKS), CAUSING SECOND DEGREE BURN ON CERVICAL, SCALP AND SOME HAIR STRANDS. THE BURNED BODY SURFACE AREA WAS APPROXIMATELY 0.5% TO 1%, AFFECTING A RIGHT LATERAL STRIP OF THE SCALP AND A SMALL AREA ON THE RIGHT EAR. CLEANED THE BURNED AREA WITH 0.9% SALINE SOLUTION AND APPLIED AN OCCLUSIVE DRESSING WITH AQUACEL AG (HYDROFIBER WITH SILVER) AND CREPE BANDAGE. SUBSEQUENTLY, USED 1% SILVER SULFADIAZINE CREAM, CHANGING THE DRESSING DAILY. THE NON-MEDTRONIC BRAND RETURN ELECTRODE PLATE WAS LOCATED AT THE BACK OF THE LEFT THIGH. PHOTO OBSERVATION SHOWED FIRST DEGREE BURN. THE PATIENT WAS OKAY, WITHOUT INJURIES.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 21861747 ↗
• MalfunctionNov 18, 2024Unintended Power Up; Inappropriate/Inadequate Shock/Stimulation; Unintended Power Up; Inappropriate/Inadequate Shock/Stimulation

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE, ONE SURGEON GOT AN ELECTRIC SHOCK WHILE LEANING ON A DIATHERMY INSTRUMENT (E2100) ON TOP OF A PATIENT. THE SMOKE EVACUATOR HAD STARTED, WHICH REFERS TO INADVERTENT BUTTON DEPRESSION IN DIATHERMY INSTRUMENT. IN ADDITION, THE MAGNETIC MAT HAD A METAL SUCTION TIP AND DIATHERMY ON WHICH THE SURGEON'S HAND RESTED. THE DEVICES WERE CHECKED IMMEDIATELY AFTER THE PROCEDURE BY A MEDICAL TECHNICIAN AND NO FAULT WAS FOUND. THE ELECTRICAL PLUGS IN THE OPERATING ROOM WERE ALSO CHECKED, AND NO EARTH LEAKAGE HAS OCCURRED - AN EARTH LEAKAGE WOULD HAVE TRIGGERED AN ALARM.

  Patient problems: Electric Shock

  MAUDE report 20707328 ↗
• MalfunctionMay 14, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, DURING THE ACTIVATION OF THE PENS, THERE WAS A MALFUNCTION. HARD BUTTONS THAT ARE DIFFICULT TO OPERATE; CUT BUTTON WAS STUCK IN CONSTANT ACTIVATION. THE TEAM THAT USES THIS MATERIAL IN THE HOSPITAL WAS USED TO USING IT AND THE LAST BATCH PURCHASED SHOWED THIS IRREGULARITY.

  Patient problems: Insufficient Information

  MAUDE report 19312417 ↗
• MalfunctionApr 19, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, DURING THE ACTIVATION OF THE PENS, THERE WAS A MALFUNCTION. HARD BUTTONS THAT ARE DIFFICULT TO OPERATE; CUT BUTTON WAS STUCK IN CONSTANT ACTIVATION. THE TEAM THAT USES THIS MATERIAL IN THE HOSPITAL WAS USED TO USING IT AND THE LAST BATCH PURCHASED SHOWED THIS IRREGULARITY. THE PRODUCT WAS REPLACED BY ANOTHER AND THE PROCEDURE CONTINUED NORMALLY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19145159 ↗
• MalfunctionApr 19, 2024Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, DURING THE ACTIVATION OF THE PENS, THERE WAS A MALFUNCTION. HARD BUTTONS THAT ARE DIFFICULT TO OPERATE; CUT BUTTON WAS STUCK IN CONSTANT ACTIVATION. THE TEAM THAT USES THIS MATERIAL IN THE HOSPITAL WAS USED TO USING IT AND THE LAST BATCH PURCHASED SHOWED THIS IRREGULARITY. THE PRODUCT WAS REPLACED BY ANOTHER AND THE PROCEDURE CONTINUED NORMALLY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19144780 ↗
• MalfunctionAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Burn(s)

  MAUDE report 17606985 ↗
• MalfunctionFeb 17, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE ACTIVATE WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397643 ↗
• MalfunctionFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD A BURN FROM THE GENERATOR AND MONOPOLAR PENCIL, AND THE UNIT WAS GETTING HOT DURING USE. BURN WOUND WAS 5-7CM ON THE CHEST WAS COOLED AND TREATED WITH HYDRO-ACTIVE COLLOID GEL.

  Patient problems: Burn(s)

  MAUDE report 16330005 ↗
• MalfunctionDec 19, 2022Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SHORTLY AFTER THE OPERATION STARTED, THE DOCTOR COMMENTED THAT THE DEVICE WOULD NOT TURN ON (30W SETTING), BUT THE OPERATION WAS CONTINUED WITHOUT CHANGING THE W SETTING. THE ELECTROCAUTERY CORD WAS TIED TO A DRAPE AND FIXATED WITH A CLOTH. BECAUSE THE FOCUS WAS ON THE SURGICAL FIELD, NOBODY HAS SEEN THE AREA NEAR THE CLOTH WHERE THE FIRE OCCURRED, BUT IT BURNED. IMMEDIATELY AFTERWARDS, A HOLE APPEARED AND WAS BURNED IN THE SURGICAL GOWN OF THE PHYSICIAN WHO WAS NEARBY, JUST AROUND THE STOMACH AREA OF THE GOWN. AFTER THAT, THE GENERATOR WAS CHANGED FROM MEGA SOFT TO TRIAD, AND THE RETURN ELECTRODES WERE THE SAME, AND A SPARE PENCIL WAS USED. THE GENERATOR WAS POSITIONED TOWARDS THE PATIENT'S HEAD SIDE. AFTERWARDS, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THE FIRE WAS EXTINGUISHED IMMEDIATELY AFTER THEY SMELLED SOMETHING BURNING, SO NOBODY REMEMBERED THE SIZE. THE FIRE WAS EXTINGUISHED REFLEXIVELY, SO NOBODY REMEMBER HOW IT WAS EXTINGUISHED. THERE WAS NO OPERATING ROOM FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011068 ↗
• MalfunctionDec 21, 2021Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DID NOT ACTIVATE. ANOTHER DEVICE WAS USE AND WORKED FINE. THE INITIAL INVESTIGATION DETECTED A UNREPORTED CONDITION OF SELF-ACTIVATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053873 ↗
• MalfunctionDec 17, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PENCIL DEVICE HAD A SELF-ACTIVATION ISSUE. THE DEVICE ACTIVATED WITHOUT PRESSING THE ACTIVATION BUTTON EVEN THE "ON" BUTTON WAS IN A TURN OFF POSITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025802 ↗
• MalfunctionDec 10, 2021Inappropriate/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 USE, THE SURGEON HAD A BLACK DOT AROUND LESS THAN 5MM IN DIAMETER ON HAND. NO TREATMENT DONE ON THE SURGEON¿S HAND AND CONDITION WAS GETTING BETTER ON THE NUMBNESS. THE DEVICE SHOCKED SURGEON'S HAND.

  Patient problems: Burn(s)

  MAUDE report 12977712 ↗
• MalfunctionJun 4, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS SELF-ACTIVATED THE FIRST TIME THE NURSE PLUGGED IT INTO GENERATOR (FORCE FX) AND THE LIGHT IN GENERATOR SHOWED "CUT" WITH LIGHT ON (YELLOW) WITHOUT ACTIVATION IN BUTTON OR FOOT-SWITCHING. IT WAS TESTED AND ATTACHED TO TWO DIFFERENT GENERATORS, IT HAD SIMILAR ERROR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940138 ↗
• MalfunctionApr 26, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT DEVICE HAD AN ACTIVATION ISSUE AND WAS SELF ACTIVATING. THE ACTIVATION BUTTON OR S WITCH WAS IN THE "ON" POSITION AND THE INSTRUMENT ACTIVATED WITHOUT PRESSING THE ACTIVATION BUTTON OR SWITCH. REPLACED THE DISSECTOR WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729625 ↗
• MalfunctionFeb 1, 2021Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, WHEN THE PENCIL WAS USED IN CONJUNCTION WITH THE EQUIPMENT, IT HAD INTERMITTENT AND SPONTANEOUS ACTIVATION OF CUT FUNCTION WHEN THE COAGULATION FUNCTION WAS ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259903 ↗
• MalfunctionNov 25, 2020Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, WHEN THE BUTTON WAS PRESSED, ACTIVATION WAS PERFORMED. HOWEVER, EVEN WHEN PULLING AWAY, ACTIVATION DID NOT STOP BUT CONTINUED.

  Patient problems: Insufficient Information

  MAUDE report 10905028 ↗
• MalfunctionNov 24, 2020Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, THE DEVICE MELTED. THERE WAS LOW-TEMPERATURE PLASMA DISINFECTION. THE DOCTOR USED TWO TO THREE TIMES; THE DISSECTOR PEN HANDLE APPEARED PEELING AND WITH STICKY PHENOMENON. WHEN THE DOCTOR WAS OPERATING THE KNIFE AND PEN, THE GLOVES STUCK TO THE KNIFE AND PEN, AND THE PEN BARREL PART OF THE KNIFE AND PEN WAS DETACHED FROM THE SCUM AND CANNOT BE USED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10894473 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING HIGH LIGATION OF THE RIGHT PERITONEAL SHEATH, THE PATIENT SUFFERED ECTOPIC BURNS DURING THE PROCEDURE IN THE GROIN AND PERINEUM. THE GROUNDING PAD WAS PLACED IN THE UPPER LEFT ABDOMEN OF THE PATIENT. IT WAS NOTED THAT THERE WAS TISSUE DAMAGE DUE TO BURNS FROM THE ROOTS OF THE LEGS TO THE LOWER ABDOMEN. THE PATIENT RECOVERED.

  Patient problems: Burn(s)

  MAUDE report 10745718 ↗
• MalfunctionOct 15, 2019Fire; Arcing; Adverse Event Without Identified Device or Use Problem; Fire; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER THE PATIENT WAS PREPARED IN THEATRE FOR SURGERY, WHEREIN THE UNIVERSAL ADULT RETURN ELECTRODE WAS PLACED ON THE LOWER GLUTEAL REGION AND THE SITE OF INCISION WHICH IS THE LOWER ABDOMEN WAS STERILIZED USING POVIDONE IODINE AND METHYLATED SPIRIT, BEFORE SKIN DRIED OUT ENTIRELY, PENCIL CONNECTED TO THE FX8 GENERATOR WAS ACTIVATED. UPON THE PENCIL'S CONTACT WITH THE SKIN OF THE CUTTING SITE, A SPARK OCCURRED THAT TRIGGERED A FIRE. THE PATIENT SUSTAINED BURNS.

  Patient problems: Burn(s)

  MAUDE report 9195072 ↗
• MalfunctionSep 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PENCIL WERE WRINKLED AND STRIPPED FROM THEIR OUTER SHELL OF THE WIRES EVENTUALLY TEARING APART DURING USE AND AUTOCLAVE WHICH WAS DONE ACCORDING TO THE INSTRUCTIONS.

  Patient problems: No Information

  MAUDE report 9072160 ↗
• MalfunctionSep 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PENCIL WERE WRINKLED AND STRIPPED FROM THEIR OUTER SHELL OF THE WIRES EVENTUALLY TEARING APART DURING USE AND AUTOCLAVE WHICH WAS DONE ACCORDING TO THE INSTRUCTIONS.

  Patient problems: No Information

  MAUDE report 9071949 ↗