ELAN 4 GA800Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963794255), received between Feb 26, 2021 and Jul 19, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2021Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED TO AESCULAP AG THAT A ELAN 4 ELECTRO CONTROL UNIT (PART # GA800) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE HANDLE OF THE ELECTRIC POWER SYSTEM SUDDENLY STOPPED WORKING. THE HANDLE WAS REPLACED, AND THEN THE PROCEDURE WAS ABLE TO BE CONTINUED AND SUCCESSFULLY COMPLETED. 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 12190788 ↗
• MalfunctionMar 23, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA800 - ELAN 4 ELECTRO CONTROL UNIT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE TURNED OFF AND RESTARTED AUTOMATICALLY DURING SURGERY. THIS MALFUNCTION CAUSED A SURGERY DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553244 ↗
• MalfunctionFeb 26, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO AESCULAP THAT A ELAN 4 ELECTRO CONTROL UNIT (PART # GA800) WAS TO BE USED DURING A LAMINECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE DEVICE DID NOT WORK CORRECTLY. REPORTEDLY, WHEN THE CONTROL UNIT WAS PLUGGED IN, IT BEGAN ITS NORMAL STARTUP PROCEDURE. HOWEVER, WHEN THE HAND-CONTROL CORD WAS PLUGGED INTO THE UNIT, THE DISPLAY FLASHED RED, THEN BLACK, AND RETURNED TO THE STARTUP PROCEDURE. THE UNIT WAS RESET, BUT THE ERROR RECURRED. ADDITIONALLY, DUE TO THE RURAL LOCATION OF THE FACILITY, ANOTHER CONTROL UNIT WAS NOT IMMEDIATELY AVAILABLE, WHICH RESULTED IN THE CANCELLATION OF THE CASE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387904 ↗