N/A 1885078HSERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994233233), received between Aug 21, 2017 and Aug 13, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THROUGH A MANUFACTURER REPRESENTATIVE (REP) THAT DURING CASE A BUR WAS USED AND THAT IT APPEARED THAT THE PATIENT HAD A BURN ON THEIR UPPER LIP FROM WHERE THE SHAFT OF THE BUR WAS TOUCHING THE PATIENTS FACE. CORRECTIVE MEASURES INCLUDED THE IMMEDIATE REMOVAL OF DRILL AND IRRIGATION WITH COOL STERILE SALINE; PLACEMENT OF MUPIROCIN OINTMENT AND MEPILEX OVER THE BURN FOR REMAINDER OF CASE, AND DAILY WOUND CARE WITH BACITRACIN BID. IT WAS NOTED THAT THE BURN WAS 2ND DEGREE AND THEY DID NOT BELIEVE THAT THE DEVICE WAS REPROCESSED OR RE-USED. NO ADDITIONAL COMPLICATIONS WERE REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE BUR WAS BEING HELD BY THE ANALYSIS TEAM AT THE FACILITY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7777071 ↗
• MalfunctionAug 21, 2017Break; Break

  THE FACILITY REPORTED THAT A BUR BROKE AT THE BASE DURING THE PROCEDURE. ANOTHER BUR WAS OPENED AND THE SAME PROBLEM OCCURRED. THE BURS BROKE WITHIN A MINUTE OF THEM BEING USED. A THIRD BUR FROM A DIFFERENT LOT WAS OPENED AND THERE WAS NO ISSUE. THE BROKEN BURS DID NOT RESULT IN FRAGMENTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807383 ↗