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RobotRisk / Intuitive Surgical (da Vinci-compatible surgical staplers) / 2026-03-18

FDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries

S4 · 03/18
2026 · Intuitive Surgical (da Vinci-compatible surgical staplers) · USA

Record

CompanyIntuitive Surgical (da Vinci-compatible surgical staplers)
Categoryother
Typeregulatory
Date03/18
2026
Time of daynot documented
LocationUSA
SeverityS4 (serious injury, total loss, or grounding)
Scale-
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceHealthExec

What happened

The FDA issued an emergency alert for surgical stapler reloads used with da Vinci robotic surgical systems after reports of 1 death and 4 injuries.

Intuitive Surgical (da Vinci-compatible surgical staplers) record context

Intuitive Surgical (da Vinci-compatible surgical staplers) vs other alternatives

other context

other: entries by year

14282017 S1: 12017 S5: 12172019 S3: 11192021 S3: 11212022 S5: 11222023 S3: 12023 S4: 23232024 S1: 22024 S2: 42024 S3: 32024 S4: 72024 S5: 521242025 S1: 12025 S2: 72025 S3: 62025 S4: 82025 S5: 628252026 S1: 12026 S2: 92026 S3: 32026 S4: 22026 S5: 31826
S1S2S3S4S5

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regulatory context

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