Intuitive Surgical Cobra Grasper Surgical Instruments Recalled for Cable Fraying
Intuitive Surgical is recalling 2,472 Cobra Grasper surgical instruments due to frayed or broken grip cables that may affect surgical procedures.
What this means for you
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 recall of surgical instruments with a functional defect (frayed or broken grip cables) that presents a risk of harm during surgical use. No injuries or adverse outcomes are reported in the source material, meeting the rubric criterion for High (Score 3): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Intuitive Surgical, Inc. is recalling 2,472 units of its 8MM Cobra Grasper (Model 471190) surgical instruments with jaws. The recall is due to increased complaints regarding frayed or broken grip cables on the reusable instruments. Cable defects may impair proper functioning during surgical use.
The affected instruments were distributed throughout the United States, including all 50 states, the District of Columbia, and Puerto Rico. International distribution includes countries across Europe, Asia, the Americas, Australia, Africa, and the Middle East. Affected batch numbers are K10230226, K10230405, K10230413, K10230420, K10231005, K10231019, K10231130, K10240104, K10240111, K10240118, K10240327, K10240418, K10240502, K10240606, and K10240725.
Facilities and users with affected instruments should discontinue use and contact Intuitive Surgical for instructions on replacement or further guidance.
The recalled product
- Product
- 8MM,COBRA GRASPER,IS4000 REF 471190
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 2,472
Distribution
Part of a larger recall action
This product is one of 37 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.
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