Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding
[RECALL]Mar 17, 2022 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Mar 17, 2022
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Intuitive recalled da Vinci X/Xi SureForm 45 staplers (REF 480445 / 480545 / 480460) because tissue pushout during stapler firing could cause critical bleeding. Distinct failure mode and Z-number from the same-era SureForm staple-fragment recall already recorded. Source: FDA Class 2 device recall Z-0999-2022, openFDA enforcement / accessdata.fda.gov.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=192324
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=192324
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Details
Incident Context & FAQ
What happened in Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
Intuitive recalled da Vinci X/Xi SureForm 45 staplers (REF 480445 / 480545 / 480460) because tissue pushout during stapler firing could cause critical bleeding. Distinct failure mode and Z-number from the same-era SureForm staple-fragment recall already recorded. Source: FDA Class 2 device recall Z-0999-2022, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on March 17, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
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 Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.