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Incident · Injury

da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)

An FDA MAUDE injury report describes a da Vinci SP case in which the patient experienced abdominal pain, bleeding, and a wound infection. Source: FDA MAUDE MDR key 25322546, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

Occurred 2025-06-18 · Intuitive Surgical · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.

Machine-readable surfaces

Sources (3)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  2. https://www.intuitive-surgical.com/
  3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=25322546&pc=NAY

Common questions

What happened in da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)?
An FDA MAUDE injury report describes a da Vinci SP case in which the patient experienced abdominal pain, bleeding, and a wound infection. Source: FDA MAUDE MDR key 25322546, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on June 18, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)?
The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (2 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

2
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE).

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Canonical ID 170aa13e-b0bd-4239-860d-df495c4c5318