ELAN 4 GP176RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964558863), received between May 23, 2017 and May 23, 2017 — 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.

• MalfunctionMay 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP (B)(4) THAT AN ELAN 4 1-RING DIAMOND BURR X-COARSE D7.0 (PART # GP177R) (REF. ASSOCIATED MDR ID 2916714-2016-01047), AN ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0 (PART # GP176R), AN ELAN 4 1-RING DIAMOND BURR COARSE D4.0 (PART # GP168R) (REF. ASSOCIATED MDR ID 2916714-2016-01049), AND AN ELAN 4 1-RING DIAMOND BURR COARSE D5.0 (PART # GP169R) (REF. ASSOCIATED MDR ID 2916714-2016-01050), WERE USED DURING AN EARS, NOSE AND THROAT (ENT) PROCEDURE. ACCORDING TO THE COMPLAINANT, DIAMOND GRAINS WERE OBSERVED FALLING FROM THE DEVICE BURRS INTO THE OPERATING AREA. THE SURGEON IMMEDIATELY OBSERVED THE GRAINS THROUGH THE MICROSCOPE AND REMOVED THEM FROM THE SITE. NO KNOWN PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 6586458 ↗