Intuitive recalls da Vinci Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients

[RECALL]

Dec 23, 2021 · Intuitive Surgical · da Vinci (and Ion) · South Korea

Failure Mode

RECALL

Event Date

Dec 23, 2021

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 the da Vinci Xi/X Conductive Cannula Reducer because the metal tip could dislodge and remain inside the patient, a retrieval-surgery risk. 149,646 units. Source: FDA Class 2 device recall Z-0702-2022, accessdata.fda.gov / openFDA enforcement.

System & Fleet Architecture

Operating Manufacturer

Intuitive SurgicalView Manufacturer

Hardware Platform

da Vinci (and Ion)

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=190985

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=190985

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Intuitive recalls da Vinci Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients?

Intuitive recalled the da Vinci Xi/X Conductive Cannula Reducer because the metal tip could dislodge and remain inside the patient, a retrieval-surgery risk. 149,646 units. Source: FDA Class 2 device recall Z-0702-2022, accessdata.fda.gov / openFDA enforcement.

When did this incident occur?

The incident is recorded as occurring on December 23, 2021 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 Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients?

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 Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients?

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 Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.