NA 5820009030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540670076), received between May 14, 2019 and Jan 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2023Delivered as Unsterile Product; Expiration Date Error; Delivered as Unsterile Product; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCT WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16231782 ↗
• MalfunctionMay 14, 2019Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE WHILE REMOVING THE BUR FROM THE ATTACHMENT THE SURGEON EXPERIENCED A MINOR/SMALL BURN TO HIS FINGER. IT WAS FURTHER REPORTED THAT NO TREATMENT WAS REQUIRED FOR THE BURN AND NO FOLLOW UP TREATMENT REQUIRED. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ANOTHER DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8607515 ↗