Gyrus ACMI AE-1Recalls & reported problems
Gyrus ACMI, LLC · Endoscopic Instrument Lubricant (3/PK) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925038110), received between Mar 29, 2021 and Nov 8, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2023Off-Label Use; Off-Label Use
THE CUSTOMER REPORTED TO OLYMPUS, THE ENDOSCOPIC INSTRUMENT LUBRICANT WAS USED ON THE PATIENT WHICH WAS AN OFF-LABEL USE. THE CUSTOMER USED THE LUBRICANT TO HELP PASS THE SCOPE DOWN THE PATIENT. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18097506 ↗MalfunctionDec 15, 2021Off-Label Use; Off-Label Use
THE CUSTOMER CALLED IN AND INQUIRED IF OLYMPUS HAS A LUBRICANT FOR THE BF SCOPES FOR INSERTION, THEY ARE USING AE-1. THE ISSUE FOUND DURING AN UNSPECIFIED PROCEDURE. CUSTOMER STATED THEY HAVE BEEN USING AE-1 FOR YEARS AS A LUBRICANT FOR PATIENTS. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13012213 ↗MalfunctionMar 29, 2021Off-Label Use; Off-Label Use
IT WAS REPORTED THAT THE CUSTOMER HAVE BEEN USING THE AE-1 TO LUBRICATE THE BRONCHOSCOPE TO GLIDE THROUGH ETT¿S (ENDOTRACHEAL TUBE).THE LUBRICANT IS BEING USED ON THE EXTERIOR OF THE BRONCHOSCOPE AS A LUBRICANT FOR EASY PASSAGE INTO ETT AND PLACEMENT OF DOUBLE LUMEN ETT FOR THORACIC SURGERY ONE LUNG VENTILATION. THIS LUBRICANT IS INTENDED ONLY FOR SILICONE LUBRICANT FOR ENDOSCOPIC STOPCOCK VALVES. IT IS NOT INTENDED FOR PATIENT CONTACT. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11586092 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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