ELAN 4 GA824Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963793876), received between Jul 20, 2020 and Jul 20, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 20, 2020Overheating of Device; Temperature Problem; Temperature Problem

  ASSOCIATED MEDWATCH-REPORTS: 2916714-2020-00243 (400476403 + GA824), AND 2916714-2020-00242 . INVOLVED COMPONENTS: GD450M - MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM - SERIAL NO. 2017 1006319. ADDITIONAL INFORMATION RECEIVED VIA INFORMATION FROM MW5095342: THE PATIENT WAS A SIX YEAR-OLD FEMALE. THE DEVICE WAS USED A PROCEDURE FOR MAXILLARY HYPOPLASIA, MANDIBULAR HYPOPLASIA, APERTOGNATHIA AND ASYMMETRY. THE PATIENT UNDERWENT A LEFORT 1 SEGMENTAL 3-PIECE OSTEOTOMY, BILATERAL SAGITTAL SPLIT OSTEOTOMY AND GENIOPLASTY. UPON USING THE LEDEMANN BUR, IT WAS NOTED THAT THE AESCULAP DRILL BECAME VERY HOT; DURING THE REMOVAL OF THE DRILL FROM THE PATIENT'S MOUTH, IT WAS NOTED THAT THE EXTENSION OF THE HAND PIECE WAS HOT AND HAD BURNED THE PATIENT'S LOWER RIGHT LIP. COLD SALINE WAS PLACED ON THE LIP IMMEDIATELY, AND SILVER SULFADIAZINE WAS PLACED, AND CONTINUED TO BE PLACED THROUGHOUT THE CASE. A NEW DRILL WAS REQUESTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, THE STERILIZATION PROCESS WAS REVIEWED AND NO FAILURES IN THE STERILIZATION OF THE DEVICE WERE NOTED.

  Patient problems: Burn, Thermal; Superficial (First Degree) Burn

  MAUDE report 10297687 ↗
• InjuryJul 20, 2020Overheating of Device; Overheating of Device

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00267 (400476402 + GD450M) INVOLVED COMPONENTS: GD450M - MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM - SERIAL NO.(B)(6). ADDITIONAL INFORMATION RECEIVED VIA INFORMATION FROM (B)(4): THE PATIENT WAS A SIX YEAR-OLD FEMALE. THE DEVICE WAS USED IN A PROCEDURE FOR MAXILLARY HYPOPLASIA, MANDIBULAR HYPOPLASIA, APERTOGNATHIA AND ASYMMETRY. THE PATIENT UNDERWENT A LEFORT 1 SEGMENTAL 3-PIECE OSTEOTOMY, BILATERAL SAGITTAL SPLIT OSTEOTOMY AND GENIOPLASTY. UPON USING THE LEDEMANN BUR, IT WAS NOTED THAT THE AESCULAP DRILL BECAME VERY HOT; DURING THE REMOVAL OF THE DRILL FROM THE PATIENT'S MOUTH, IT WAS NOTED THAT THE EXTENSION OF THE HAND PIECE WAS HOT AND HAD BURNED THE PATIENT'S LOWER RIGHT LIP. COLD SALINE WAS PLACED ON THE LIP IMMEDIATELY, AND SILVER SULFADIAZINE WAS PLACED, AND CONTINUED TO BE PLACED THROUGHOUT THE CASE. A NEW DRILL WAS REQUESTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, THE STERILIZATION PROCESS WAS REVIEWED AND NO FAILURES IN THE STERILIZATION OF THE DEVICE WERE NOTED.

  Patient problems: Burn, Thermal

  MAUDE report 10297686 ↗