da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)
[INJURY]Jun 18, 2025 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
INJURY
Event Date
Jun 18, 2025
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Inspect Filing
https://www.intuitive-surgical.com/
https://www.intuitive-surgical.com/
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=25322546&pc=NAY
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=25322546&pc=NAY
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Details
Incident Context & FAQ
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.
What robot was involved in da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
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.