Formula 0375704500Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327057638), received between Mar 26, 2019 and Dec 4, 2024 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT OF SMOKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849394 ↗
• MalfunctionDec 4, 2024Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT OF SMOKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848910 ↗
• MalfunctionDec 4, 2024Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT OF SMOKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848743 ↗
• MalfunctionDec 4, 2024Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT OF SMOKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848659 ↗
• MalfunctionDec 4, 2024Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT OF SMOKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847320 ↗
• MalfunctionApr 19, 2023Continuous Firing; Continuous Firing

  IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770515 ↗
• MalfunctionApr 13, 2022Overheating of Device

  IT WAS REPORTED THAT THE DEVICE BECAME HOT DURING USE. PLEASE NOTE, THE PATIENT OR USER WERE NOT BURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106757 ↗
• MalfunctionFeb 16, 2022Continuous Firing; Failure to Shut Off; Continuous Firing; Failure to Shut Off

  IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY ACTIVATING.

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

  MAUDE report 13546308 ↗
• InjuryNov 18, 2021Insufficient Cooling; Adverse Event Without Identified Device or Use Problem; Insufficient Cooling

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn(s)

  MAUDE report 12838112 ↗
• MalfunctionAug 2, 2021Self-Activation or Keying; Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY ACTIVATING.

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

  MAUDE report 12264132 ↗
• MalfunctionFeb 18, 2021Insufficient Cooling; Insufficient Cooling; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE BECAME HOT DURING USE.

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

  MAUDE report 11346551 ↗
• MalfunctionJan 25, 2021Insufficient Cooling; Insufficient Cooling; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE BECAME HOT DURING USE.

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

  MAUDE report 11225110 ↗
• MalfunctionDec 18, 2020Insufficient Cooling; Device Emits Odor; Overheating of Device; Insufficient Cooling

  IT WAS REPORTED THAT THE DEVICE HEATED UP DURING THE PROCEDURE PRODUCING A BURNT PLASTIC SMELL.

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

  MAUDE report 11041636 ↗
• MalfunctionDec 18, 2020Insufficient Cooling; Device Emits Odor; Overheating of Device; Insufficient Cooling

  IT WAS REPORTED THAT THE DEVICE HEATED UP DURING THE PROCEDURE PRODUCING A BURNT PLASTIC SMELL.

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

  MAUDE report 11041563 ↗
• MalfunctionDec 2, 2020Insufficient Cooling; Adverse Event Without Identified Device or Use Problem; Insufficient Cooling

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 10936986 ↗
• MalfunctionDec 12, 2019Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE GOT HOT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9461756 ↗
• MalfunctionNov 13, 2019Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE OVERHEATED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9316201 ↗
• MalfunctionAug 26, 2019Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge

  IT WAS REPORTED THAT THE SURGEON WAS SHOCKED BY THE PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient; Shock

  MAUDE report 8932399 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn, Thermal

  MAUDE report 8727113 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn, Thermal

  MAUDE report 8727112 ↗
• MalfunctionApr 2, 2019Overheating of Device

  IT WAS REPORTED THAT THE PRODUCT GOT HOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474335 ↗
• MalfunctionMar 26, 2019Overheating of Device

  IT WAS REPORTED THAT THE PRODUCT HEATED UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453152 ↗