Intuitive recalls da Vinci 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients
[RECALL]Aug 15, 2018 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Aug 15, 2018
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Certain lots of the da Vinci S/Si and X/Xi 8mm Monopolar Curved Scissors were susceptible to cracks near the proximal edge of the extension tube; a crack could fracture the plastic around the instrument shaft and let fragments fall, potentially into the patient. Intuitive issued an Urgent Medical Device Notification advising pre-use inspection.
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=166175
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=166175
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Details
Incident Context & FAQ
What happened in Intuitive recalls da Vinci 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients?
Certain lots of the da Vinci S/Si and X/Xi 8mm Monopolar Curved Scissors were susceptible to cracks near the proximal edge of the extension tube; a crack could fracture the plastic around the instrument shaft and let fragments fall, potentially into the patient. Intuitive issued an Urgent Medical Device Notification advising pre-use inspection. Distinct from the 2013 Hot Shears tip-insulation recall. Source: FDA Class 2 device recalls Z-3024-2018 (S/Si, 23,064 units) and Z-3025-2018 (X/Xi, 42,274 units), accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on August 15, 2018 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 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into 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 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into 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 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.