ELAN 4 GP452SURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964725975), received between Jul 12, 2021 and Jul 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP AG THAT AN ELAN 4 MIS L13 DISP. DIAMOND BURR D3.0 (PART # GP452SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(4) 2021. ACCORDING TO THE COMPLAINANT, WHILE PERFORMING A CLINICAL EVALUATION IN THEATRE, THE SURGEON HAD BEEN BURRING FOR APPROXIMATELY TEN (10) MINUTES AT 80,000 ROTATIONS PER MINUTE (RPM) USING THE ELAN 4 MIS HANDPIECE FROM AN ELSA SET. THE DRILL SUDDENLY STOPPED WORKING AND THE DISTAL END DROPPED OUT OF THE MIS HANDPIECE SHAFT. AS THE BURR WAS CHANGED, THE FIRST BURR CAME OUT IN TWO PIECES AS IT HAD SNAPPED IN TWO. A SLIGHT SURGICAL DELAY OF APPROXIMATELY THIRTY (30) SECONDS WAS REPORTED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149946 ↗