Formula 0375951012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327054842), received between Oct 30, 2019 and Aug 28, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092082 ↗
• MalfunctionMay 25, 2022Overheating of Device; Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE WAS GETTING HOT AND BURNT THROUGH THE SURGEON'S GLOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 14496628 ↗
• InjurySep 23, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 10577736 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9256575 ↗