Da Vinci Clip Applier Recall: Risk of Unexpected Instrument Motion
Intuitive Surgical is recalling 62,895 Da Vinci S/Si Clip Appliers worldwide due to potential unexpected motion from partial instrument disengagement. No injuries or illnesses have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product. No illnesses, injuries, or deaths have been reported. The hazard is a potential risk rather than confirmed actual harm, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling three models of Da Vinci S/Si Clip Appliers: the Large Clip Applier (Model 420230), Medium-Large Clip Applier (Model 420327), and Small Clip Applier (Model 420003). These are surgical instruments used with the Da Vinci S/Si surgical robotic system.
The recall was issued due to the potential for unexpected motion caused by partial disengagement of the instrument from the system during use. This creates a risk of harm to patients during surgical procedures.
Approximately 62,895 of these clip appliers have been distributed worldwide, including throughout the United States and to numerous countries globally. The recall affects all serial numbers of the three affected models.
The recalled product
- Product
- Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 62,895
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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