DIEGO ELITE BUR3070DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925038257), received between Aug 20, 2020 and Feb 18, 2021 — classified as 2 malfunctions.

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.

• MalfunctionFeb 18, 2021Break; Break

  THE USER FACILITY REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE DEVICE DID NOT WORK AS INTENDED. THE BURR HAD INITIALLY WORKED, THEN EVENTUALLY STOPPED COMPLETELY. A CONSOLE AND TWO (2) SEPARATE HANDPIECES WERE USED WITH THE BURR FOR TESTING, HOWEVER THE ISSUE REMAINED. THE DRILL WAS TAKEN FROM THE HANDPIECE AND IT WAS OBSERVED THAT PART OF THE WHITE PIECE OF PLASTIC IN THE DRILL WHERE THE DRILL IS INSERTED INTO THE HANDPIECE WAS CHIPPED UP. THE PROCEDURE WAS PROLONGED OVER AN HOUR AND WAS THEN ABORTED DUE TO A LACK OF BURRS. THE PATIENT HAD TO BE RESCHEDULED FOR A NEW PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. THE USER FACILITY LATER REPORTED THAT THE REASON WHY THE BURRS BROKE WAS THAT THEY WERE USED ON A PATIENT WITH AN OSTEOMA. THE BONE TISSUE WAS TOO HARD FOR THE BURR TO DRILL AWAY. THE ROTATION SPEED OF THE SHAVER BECAME TOO SMALL TO HANDLE THIS. THE CUSTOMER ACKNOWLEDGED THAT BURRS WERE USED IN A PROCEDURE THEY ARE NOT INTENDED TO BE USED IN. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(6) AND (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11344179 ↗
• MalfunctionAug 20, 2020Melted; Defective Device; Melted; Defective Device

  IT WAS REPORTED THAT DURING A FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) PROCEDURE, THE GEARS WITHIN THE HANDPIECE OF THE DEVICE THAT CONNECT TO THE BURR WERE DISINTEGRATED/MELTED (AS DESCRIBED BY THE REPORTER) DURING USE. ACCORDING TO THE REPORTER THERE WAS NO DAMAGE TO THE HANDPIECE OR THE GEAR THAT DRIVES THE BLADE MECHANISM. THE PLASTIC THAT MELTED WAS AT THE POINT WHERE THE BLADE INTERLOCKS WITH THE MECHANISM OF THE TUBE SET. THE HANDPIECE ALONG WITH THE TUBE SET WERE REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE WAS NO PATIENT HARM OR INJURY REPORTED ON THIS EVENT. NO USER HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431081 ↗