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Incident · Recall

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 Instrument versions corrected/superseded.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.

Occurred 2013-05-08 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns

Machine-readable surfaces

Outcomes (2)

  • regulatory actionverified
  • bodily injuryreported

Revision history (2)

  • 2026-06-05 · outcome_class
  • 2026-06-05 · outcome_class

Outcome rows carry verification_posture independently. Revision events carry basis (verified_court_filing, verified_insurance, reported_press, estimate, undisclosed). The framework records outcomes only when verifiable; absence is honest absence, not a claim of no-impact.

Sources (2)

  1. Medscape · https://www.medscape.com/viewarticle/804067
  2. YouHaveALawyer · https://www.youhavealawyer.com/blog/2013/05/13/da-vinci-robot-recall/

Common questions

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 Instrument versions corrected/superseded.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.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-07-21

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

2
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns.

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Canonical ID 4c353777-3f5f-4afa-82ed-7ebcef5d6b65