da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns
[RECALL]May 8, 2013 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
May 8, 2013
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Class I recall (Urgent Medical Device Notification May 8 2013): micro-cracks near the distal shaft on '-09'/'-10' versions of the EndoWrist Hot Shears develop after cleaning/sterilization, creating an arc path for monopolar energy to leak and burn tissue outside the surgical field (134 tip-cover complaints + 82 MDRs, Jan 2010-Dec 2011). Instrument versions corrected/superseded. The load-bearing historical da Vinci safety event.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.medscape.com/viewarticle/804067
https://www.medscape.com/viewarticle/804067
- Inspect Filing
https://www.youhavealawyer.com/blog/2013/05/13/da-vinci-robot-recall/
https://www.youhavealawyer.com/blog/2013/05/13/da-vinci-robot-recall/
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Details
Incident Context & FAQ
What happened in da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns?
Class I recall (Urgent Medical Device Notification May 8 2013): micro-cracks near the distal shaft on '-09'/'-10' versions of the EndoWrist Hot Shears develop after cleaning/sterilization, creating an arc path for monopolar energy to leak and burn tissue outside the surgical field (134 tip-cover complaints + 82 MDRs, Jan 2010-Dec 2011). Instrument versions corrected/superseded. The load-bearing historical da Vinci safety event.
When did this incident occur?
The incident is recorded as occurring on May 8, 2013 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 Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns?
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 Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.