Satin™ 4065D-20Recalls & reported problems
American Diagnostic Corp · Disposable Laryngo Handle,Medium, 20/pkg · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00634782063610), received between Sep 7, 2018 and Sep 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult or Delayed Activation1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2018Difficult or Delayed Activation; Difficult or Delayed Activation
DIFFICULT INTUBATION. HANDLE WOULD NOT MAKE METALLIC CONTACT WITH LIGHT SOURCE.
Patient problems: Airway Obstruction
MAUDE report 7856049 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.