Valleylab E2505-10FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884521038957), received between Oct 7, 2017 and Jan 29, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE DEVICE'S TUBE AND HANDLE ALMOST BROKE APART COMPLETELY. NO INJURY WAS NOTED DURING THE PROCEDURE BUT THE PARENT CONTACTED THE MEDICAL STAFF THE NEXT DAY AND NOTICED WHAT APPEARED TO BE A BURN.

  Patient problems: Burn(s)

  MAUDE report 24207300 ↗
• MalfunctionJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SUCTION COAGULATORS BURNED THROUGH ONE OF THE PHYSICIAN'S GLOVES AND BURNED HIS FINGER.

  Patient problems: Burn(s)

  MAUDE report 24144259 ↗
• MalfunctionJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUCTION COAGULATORS BURNED THROUGH ONE OF THE PHYSICIAN'S GLOVES AND BURNED HIS FINGER WITH SIZE OF A PIN TIP. SILVADENE CREAM WAS USED TO TREAT THE BURN.

  Patient problems: Burn(s)

  MAUDE report 24144238 ↗
• MalfunctionJan 8, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE BLUE TIP OF THE DEVICE BROKE FROM THE ATTACHMENT POINT AT THE HANDLE.

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

  MAUDE report 24002521 ↗
• 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 22699971 ↗
• InjuryJul 15, 2025Device Alarm System; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Device Alarm System; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING TONSILLECTOMY PROCEDURE, THE DEVICE FAILED TO PRODUCE COAGULATION THERAPY AND WAS REQUIRED TO COAGULATE FOR TONSIL REMOVAL. IT WAS REMOVED AND OPENED NEW SET, UNSUCCESSFUL, REMOVED ADAPTER AND SWITCHED TO ALTERNATIVE ADAPTER TO COMPLETE THE PROCEDURE. THE PATIENT WAS READMITTED FIVE DAYS POST-OP FOR ADDITIONAL SURGERY TO RESOLVED TONSIL HEMORRHAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22504859 ↗
• MalfunctionJun 26, 2025Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE DEVICES BROKE - THE TUBE PART (BLUE) AND HANDLE PART (WHITE) NEARLY BROKE APART COMPLETELY. THE SURGEON WAS CONCERNED THAT IT MIGHT HAVE CAUSED A BURN AND EXAMINED THE MOUTH/LIP AND DID NOT SEE ANY OBVIOUS INJURIES. A NEW SUCTION BOVIE WAS USED TO FINISH THE PROCEDURE. A DAY LATER, THE PARENT CALLED STATING THAT THEY NOTICED A RED MARK ON THE RIGHT SIDE OF THE LIP, AND IT WAS THERE FROM AFTER THE SURGERY. IT HAD WORSENED SINCE THAT TIME AND IT APPEARS TO BE A BURN. THE PATIENT HAD A 2ND DEGREE 1CM BURN WHICH WAS TREATED WITH BACITRACIN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22340109 ↗
• MalfunctionJun 26, 2025Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE DEVICES BROKE - THE TUBE PART (BLUE) AND HANDLE PART (WHITE) NEARLY BROKE APART COMPLETELY. THE SURGEON WAS CONCERNED THAT IT MIGHT HAVE CAUSED A BURN AND EXAMINED THE MOUTH/LIP AND DID NOT SEE ANY OBVIOUS INJURIES. A NEW SUCTION BOVIE WAS USED TO FINISH THE PROCEDURE. A DAY LATER, THE PARENT CALLED STATING THAT THEY NOTICED A RED MARK ON THE RIGHT SIDE OF THE LIP, AND IT WAS THERE FROM AFTER THE SURGERY. IT HAD WORSENED SINCE THAT TIME AND IT APPEARS TO BE A BURN. THE PATIENT HAD A 2ND DEGREE 1CM BURN WHICH WAS TREATED WITH BACITRACIN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22339272 ↗
• MalfunctionMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON'S RIGHT THUMB WAS BURNT THROUGH THE HANDLE/TIP OF THIS COAGULATOR DEVICE.

  Patient problems: Burn(s)

  MAUDE report 22012590 ↗
• MalfunctionSep 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, CAUTERY WAS BURNING OFF.

  Patient problems: Insufficient Information

  MAUDE report 17782679 ↗
• MalfunctionSep 20, 2023Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ADENOIDECTOMY PROCEDURE, THE DEVICE HAD INSULATION ISSUE. THE PATIENT HAD MINOR THERMAL BURN ON SOFT PALATE.

  Patient problems: Burn(s)

  MAUDE report 17780195 ↗
• MalfunctionAug 22, 2023Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD A SPARK. THERE¿S A HOLE FOR SUCTION AND WHEN SURGEON PUT FINGER OVER THE HOLE TO DO SUCTION, A JOLT CAME THROUGH AND BURNED THE GLOVE. THERE WAS NO OPERATING ROOM FIRE. WAS INJURED DURING THIS INCIDENT WITH A SMALL 2 CM BURN MARK ON FINGER TIP.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 17599326 ↗
• MalfunctionAug 4, 2023Break; Overheating of Device; Peeled/Delaminated; Defective Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Break; Overheating of Device; Peeled/Delaminated; Defective Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WAS HEAT TRANSFER FROM THE DEVICE. THE IMAGE ATTACHED SHOWED THAT THE EXTENDED SHAFT WAS BENT AND RESTS IMMEDIATELY ON THE SOFT TISSUE IN COUPLE OF SPOTS WITHIN THE PATIENT¿S MOUTH. THE DISPOSABLE DEVICE WAS REMOVED AND SEQUESTERED. A SECOND DEVICE WAS USED SUCCESSFULLY. THERE WAS SUPERFICIAL 1ST DEGREE BURN MARKS TO PATIENTS MOUTH.

  Patient problems: Airway Obstruction; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blister; Burn(s); Chills; Dehydration; Dry Skin; Emotional Changes; Fever; Pain; Scar Tissue; Swelling/ Edema; Tachycardia; Unspecified Tissue Injury

  MAUDE report 17463490 ↗
• MalfunctionJun 1, 2022Failure to Deliver Energy; Separation Problem; Failure to Deliver Energy; Separation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON BOVIED TISSUE AGAIN WHERE TISSUE HAD ADHERED ON PREVIOUS SEAL AND WAS NOT HEMOSTATIC AFTER FIRST APPLICATION OF ENERGY. THE SURGEON WAS STATING THAT IN TWO CASES THE BOVIE SEEMS TO BE STICKING TO TISSUE IN TONSILLECTOMIES, WHEN PULLING BOVIE OFF OF TONSILS TISSUE WAS ADHERED AND SURGEON HAS TO APPLY THE BOVIE AGAIN DUE TO STICKING. USING WITH FOOTPEDAL. BOTH INCIDENTS OCCURRED WITH LOT NUMBER IN THIS REPORT. FACILITY DID NOT PROVIDE PATIENT INFORMATION FOR EITHER INCIDENT OF TISSUE STICKING. PATIENT HAD TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14568661 ↗
• MalfunctionJun 1, 2022Failure to Deliver Energy; Separation Problem; Failure to Deliver Energy; Separation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON BOVIED TISSUE AGAIN WHERE TISSUE HAD ADHERED ON PREVIOUS SEAL AND WAS NOT HEMOSTATIC AFTER FIRST APPLICATION OF ENERGY. THE SURGEON WAS STATING THAT IN TWO CASES THE BOVIE SEEMS TO BE STICKING TO TISSUE IN TONSILLECTOMIES, WHEN PULLING BOVIE OFF OF TONSILS TISSUE WAS ADHERED AND SURGEON HAS TO APPLY THE BOVIE AGAIN DUE TO STICKING. USING WITH FOOTPEDAL. BOTH INCIDENTS OCCURRED WITH LOT NUMBER IN THIS REPORT. FACILITY DID NOT PROVIDE PATIENT INFORMATION FOR EITHER INCIDENT OF TISSUE STICKING. PATIENT HAD TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14568596 ↗
• MalfunctionJul 28, 2021Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY, THE SURGEON WAS CAUTERIZING A TONSIL BED AND THE SHAFT HEATED UP A FEW MILLIMETERS ABOVE THE WORKING PART OF THE CAUTERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238194 ↗
• MalfunctionNov 12, 2020Sparking

  A COMBINED SUCTION/CAUTERY DEVICE WAS BEING USED DURING AN ENT PROCEDURE IN THE OPERATING ROOM BY THE ENT SURGEON. DURING ITS USE FOR CAUTERIZATION, THERE WAS A SPARK THAT CAME THROUGH THE BLUE (INSULATION) COATING. USE OF THE DEVICE WAS STOPPED. DEVICE WAS REMOVED FROM THE SURGICAL FIELD AND A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE SURGICAL PROCEDURE. PINPOINT SIZE RED AREAS WERE NOTED ON THE PATIENT'S LOWER LIP AND NEARBY SKIN TISSUE, NO BLISTERING. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Burn, Thermal

  MAUDE report 10836474 ↗
• MalfunctionJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT DISCOVERED A LARGE LATERAL BURN IN THE TONGUE AFTER USING OF THE HAND PIECE. IT WAS DISCOVERED IN THE POST ANESTHESIA CARE UNIT (PACU). THEY USED A GENERATOR IN THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 10179591 ↗
• MalfunctionOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT GOT A BURN ON THE SOFT PALATE.

  Patient problems: Burn(s)

  MAUDE report 9143638 ↗
• MalfunctionOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD A BURN THE NEXT MORNING.

  Patient problems: Burn(s)

  MAUDE report 9143620 ↗
• MalfunctionOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD A BURN ON THE LIP THE NEXT MORNING.

  Patient problems: Burn(s)

  MAUDE report 9143603 ↗
• MalfunctionSep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A SEPTOPLASTY OF THE INFERIOR TURBINATES, A SMALL BURN WHICH WAS APPROXIMATELY 2 MM WAS FOUND ON THE PATIENT'S NOSE. THE DOCTOR DID NOT RECALL GOING ANY WHERE NEAR PATIENTS THE NOSE (NON-LETHAL / MINIMAL DAMAGE).THE BURNED SITE WAS TREATED WITH BACITRACIN OINTMENT. THE PROCEDURE WAS COMPLETED USING THE SUCTION COAGULATOR.

  Patient problems: Burn(s)

  MAUDE report 9137891 ↗
• InjuryApr 18, 2019Arcing; Arcing

  ACCORDING TO THE REPORTER, DURING RADIO FREQUENCY INFERIOR TURBINATES AND ADENOIDECTOMY, THERE WAS A FLASH REPORTED DURING ACTIVATION OF ELECTRODE AND THE GENERATOR THEN SHOWED AN ERROR AFTER BEING RESTARTED. THEY USED ANOTHER GENERATOR AND PENCIL TO COMPLETE THE PROCEDURE. THE PATIENT WAS REFERRED TO TERTIARY HOSPITAL FOR FURTHER OBSERVATION.

  Patient problems: No Code Available

  MAUDE report 8526925 ↗
• MalfunctionJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TONSILLECTOMY, ADENOIDECTOMY AND UVULECTOMY, THE GENERATOR WOULD NOT HAVE ACTIVATED IF IT DID NOT SENSE A COMPLETE CIRCUIT WITH THE PATIENT RETURN ELECTRODE. THE GENERATOR DELIVERED ENERGY, BUT WE THEY UNSURE HOW THE INADVERTENT BURNS WERE CAUSED ON THE CORNERS' OF THE PATIENT'S MOUTH. PATIENT EXPERIENCED TWO ELECTROCAUTERY 2ND DEGREE BURNS ON THE CORNERS OF MOUTH WITH LESS THAN .25CM IN SIZE. PATIENT BURN WAS NOTICED AT THE END OF THE PROCEDURE WHEN THE MOUTH GAG WAS REMOVED. THE ACCOUNT HAD (3) DIFFERENT LOT NUMBERS ON THEIR SHELF, SO THE PENCIL THAT WAS USED MUST HAVE ORIGINATED FROM ONE OF THE 3 LOTS SPECIFIED IN THE REPORT. THEY TESTED THE ESU GENERATOR WITH MY OWN VALLEYLAB REM PAD AND IT PERFORMED REGULARLY, INCLUDING THE QUALITY-CONTACT MONITORING SYSTEM. TOPICAL OINTMENT AND ORAL PAIN MEDICATION FOR PATIENT COMFORT. THEY COMPLETED THE PROCEDURE USING A MONOPOLAR ELECTROCAUTERY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8234141 ↗
• MalfunctionAug 7, 2018Difficult or Delayed Activation; Activation, Positioning or Separation Problem; Flare or Flash; Difficult or Delayed Activation; Flare or Flash

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE AS THE BUTTON WAS NOT FUNCTIONING WELL AND WHEN THE DOCTOR WAS PRESSING IT, IT WOULD START TO BURN THE DOCTOR¿S FINGER. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s); No Consequences Or Impact To Patient

  MAUDE report 7757920 ↗