Valleylab VL2610DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521196681), received between Dec 22, 2017 and Jul 10, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, WHILE REMOVING A PLATE IN AN ANKLE FRACTURE THE PATIENT WAS BURNED. THE ANKLE WAS COVERED WITH GAUZE AND WHILE THE LIMB WAS DISINFECTED WITH CITROCLOREX 2% NOT ENOUGH TIME WAS WAITED FOR THE DISINFECTANT TO EVAPORATE. THE MONOPOLAR WAS ACTIVATED AND THE GAUZE CAUGHT FIRE WHICH CAUSED A 2ND DEGREE BURN ON THE PATIENT'S FOOT/ANKLE. THE UNIT HAD A SMELL OF BURNT AND DISPLAYED ERRORS. THE PATIENT'S BURN SITE TREATED WITH A GAUZE WITH HYALURONIC ACID.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22470617 ↗
• MalfunctionApr 24, 2024Fire; Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PENCIL HAD A LITTLE FLAME AROUND THE ELECTRODE. THE SURGEON WAS SHOCKED AND DROPPED THE DEVICE, IT FELT FIRST ON THE LEG OF THE PATIENT AND THEN DOWN TO THE FLOOR AND EXTINGUISHED LIKE THAT (NO OPERATING ROOM FIRE). THE PATIENT GOT A LITTLE 4MM BURN ON HIS LEG.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 19176415 ↗
• MalfunctionMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PARATHYROID SURGERY ANTERIOR APPROACH, THE DEVICE FLAME VISIBLE THROUGH THE OPERATING FIELD, NO ELECTRIC ARC, 20CMS DISTANCE BETWEEN THE TIP OF THE SCALPEL AND THE START OF THE FIRE. THERE WAS A SECOND DEGREE BURN ON THE SIDE OF THE THIGH AND IT WAS TREATED BY OILY TULLE. FIRE WAS EXTINGUISHED BY SURGEON HAND MORE THAN A MATCH SIZE FLAME. REPLACED WITH ANOTHER DEVICE AND IT WORKED FINE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18967865 ↗
• MalfunctionSep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A PAD FROM THE "KIT PACK CARDIAC PACK" CAUGHT FIRE WHEN IT CAME INTO CONTACT WITH THE NON-ACTIVE ELECTRIC SCALPEL, IN MONOPOLAR MODE UU (USAGE UNIQUE) PLATE (SINGLE USE PRODUCT) REUSED DUE TO THE REFERENCE BEING OUT OF STOCK. THE PATIENT WAS NOT BURNED, AS THE COMPRESS WAS QUICKLY REMOVED. PROCEDURE WAS COMPLETED NORMALLY AFTER PRODUCTS CHANGED WITH COMPANY PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17767015 ↗
• MalfunctionMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY LAPAROTOMY PROCEDURE, 50 CM FROM THE PLACE OF DISSECTION ON THE ABDOMEN, A CANDLE-LIKE FIRE STARTED (CHEST AREA). CAUSE OF THE FIRE WAS UNKNOWN. THEY TOOK OUT THE FIRE BY HAND AND COMPLETED THE PROCEDURE. PATIENT HAD A 1X10CM 2ND DEGREE CHEST BURN AND WAS TREATED BY MEDICAL STAFF. PHOTOS WERE SUBMITTED SHOWING CHEST AND DRAPE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16869156 ↗
• MalfunctionFeb 16, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN USING THE ELECTROCAUTERY PENCIL THE BLUE PLASTIC FELL INTO PATIENT'S CAVITY. IT WAS BECAUSE THE BLUE PLASTIC ON THE TIP OF THE BUTTON SWITCH PENCIL WAS RUBBED OFF. THUS, RINSING WAS NECESSARY TO REMOVE THE PIECE OF PLASTIC AND SUCTION WAS USED TO RETRIEVE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387510 ↗
• MalfunctionJan 24, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN USING THE ELECTRO CAUTERY HANDPIECE, THE BLUE PLASTIC ON THE TIP OF THE CAUTERY FELL AND REMAINED IN THE SITUS. THIS WAS BECAUSE THE BLUE PLASTIC ON THE TIP OF THE BUTTON SWITCH PENCIL WAS RUBBED OFF. THEREFORE,RINSING WAS NECESSARY TO REMOVE THIS PIECE OF PLASTIC. IT WAS FULLY RETRIEVED. X-RAY WAS NOT NEEDED TO RETRIEVE/LOCATE THE DETACHED PIECE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234119 ↗
• MalfunctionNov 15, 2022Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE DURING USE ON PATIENT. WHEN USING THE ELECTROCAUTERY PENCIL, THE BLUE PLASTIC REMAINED IN THE SITUS. IT WAS BECAUSE THE BLUE PLASTIC ON THE TIP OF THE BUTTON SWITCH PENCIL WAS RUBBED OFF. THUS, IT HAD TO BE RINSED. RINSING WAS NECESSARY TO REMOVE THE PIECE OF PLASTIC. PIECE OR PART FELL INTO PATIENT'S CAVITY, BUT IT WAS FULLY RETRIEVED. THEY HAD TO USE THE SUCTION TO RETRIEVE IT. THERE MIGHT BE POST OPERATIVE INFECTION IF NOT ALL OF THE SMALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797173 ↗
• MalfunctionSep 23, 2021Arcing; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Arcing; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD ELECTRICAL ARC WHICH BURNT THE CORD/CABLE. PATIENT HAD 2ND DEGREE BURN ON THE UPPER RIGHT PARAAREOLAR WITH OBLIQUE OUTWARD ORIENTATION OF 4 CM IN LENGTH BY 1 CM IN WIDTH AT THE LEVEL OF THE AREOLA AND 6 MM IN WIDTH AT ITS TOP AND EXTERNAL PARA-AREOLAR HORIZONTAL ORIENTATION OF 1.5-2CM IN LENGTH BY 1CM IN WIDTH. PATIENT WOUND WAS CLEANED, DISINFECTED AND DRESSED WITH GREASY TULLE AFTER IDENTIFICATION OF THE BURN. NEW GREASY MESH DRESSING AT THE END OF THE PROCEDURE. LOCAL CARE THEREAFTER. PATIENT HAD THE HISTORY OF BREAST IMPLANT RUPTURED.

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

  MAUDE report 12519829 ↗
• InjuryNov 9, 2020Device Remains Activated; Self-Activation or Keying; Device Remains Activated; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING AN OPEN PAROTID BIOPSY, AT THE TIME OF RESECTION, THE ELECTROSURGICAL PENCIL SHOWED THAT THE COAGULATION AND CUTTING MECHANISM WERE STUCK (ACTIVATED). THE ACTIVATION BUTTON OR SWITCH WAS STUCK IN "ON" POSITION, AND THE DEVICE WAS ACTIVATED WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED. DESPITE OF THE TIP OF THE PENCIL BEING PROTECTED, IT GENERATED LACERATION IN THE RIGHT EAR LOBE OF APPROXIMATELY 3 MM AND IN THE LOWER AND UPPER PART OF THE SURGICAL WOUND, A SECOND ELECTROSURGICAL KNIFE WAS TAKEN AS A CIRCULAR SOLUTION AND VERIFIED THAT IT WAS IN GOOD CONDITION. THE PATIENT WAS LEFT WITH A 5 X 5 BACTIGRASS, GAUZE AND FIXOMULL, AND IN THE UPPER LACERATION OF THE SURGICAL WOUND A PROLENE POINT IS PASSED 4/0 PS-2.

  Patient problems: Laceration(s)

  MAUDE report 10808634 ↗
• MalfunctionJan 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A PIECE OF PLASTIC OF SCALPEL WAS MERGED AND PART OF IT FELL INTO THE PATIENT'S CAVITY. THE PIECE WAS FULLY RETRIEVED. THERE WAS N NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546346 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE PATIENT HAD A THIRD DEGREE BURN ON THE CORNER OF THE LIPS AND IN THE INNER MUCOSA OF THE MOUTH. PATIENT IS CURRENTLY UNDER THE OBSERVATION OF A PLASTIC SURGEON. PLASTIC SURGERY WILL BE SCHEDULED. THEY USED OTHER BRAND OF GENERATOR.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 9387668 ↗
• MalfunctionDec 22, 2017Flare or Flash; Flare or Flash

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PATIENT RECEIVED A FIRST DEGREE BURN ON THE BREAST NIPPLE. A MEGADYNE ELECTRODE WAS IN USE AS WELL. THE PENCIL WAS PLACED IN THE HOLSTER WHEN NOT IN USE AND THE GENERATOR WAS IN STANDARD 40 MODE AND SETTINGS. THE BURN WAS FOUND DURING THE SURGERY AND THERE WERE NO PICTURES OF THE BURN. IT WAS UNKNOWN HOW WAS THE BURN WAS TREATED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 7143691 ↗