Intuitive Surgical Recalls 8mm Monopolar Curved Scissors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical instrument degradation) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm Monopolar Curved Scissors. These instruments are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The affected devices are identified by part number 470179-04 and are all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
The recall was initiated because deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. The agency has classified this recall as Class II.
The affected units were distributed in the United States to Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts. Healthcare facilities should contact Intuitive Surgical, Inc. for further instructions regarding the recall.
The recalled product
- Product
- 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 509
Distribution
Part of a larger recall action
This product is one of 22 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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