I monitor vigilance and post‑market data as a daily job. I live in Annex II/IX/XIV when I’m writing Technical Files or PMCF plans, and I also keep an eye on external sources — not least MAUDE, the FDA’s Manufacturer and User Facility Device Experience database. It’s tempting to treat MAUDE like a crystal ball: search a competitor, find a pattern, fix your product. To be fair, it’s useful — but it is not what most people expect.
Near-miss vs device failure — definitions that matter
First, a quick operational distinction I use in my files (and which feeds risk-management and CAPA):
Near‑miss: an event in which a device did not cause harm but had the potential to do so (intercepted failure, recovered error, or an instance where use‑environment or user action nearly led to an incident). In ISO 14971 terms this is a hazardous situation that did not lead to harm but had potential.
Device failure / incident: a malfunction or performance issue that resulted in harm (injury, deterioration of health, or death) or a serious deterioration as defined in MDR vigilance provisions.
