Intuitive Surgical Recalls Tip Covers for Monopolar Curved Scissors
Intuitive Surgical is recalling 11,121 boxes of disposable tip covers for 8mm monopolar curved scissors due to potential sterility compromise.
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: The recall is classified as FDA Class II. The hazard is a potential sterility compromise in a medical device used in surgical procedures, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 11,121 boxes of Tip Covers for 8mm Monopolar Curved Scissors (Hot Shears). The product is a disposable accessory intended to provide dielectric insulation over a section of the scissor instrument so that RF energy is only available at the scissor blades. The tip covers are used with Intuitive Surgical Endoscopic Instrument Control Systems, including da Vinci, da Vinci S, and da Vinci Si Surgical Systems.
The recall was initiated because there is potential for the sterility of the product to be compromised. The affected product is Model No. 400180-12. The recall includes specific lot numbers: M10120601, M10120430, M10120329, M10120312, M10111214, M10120516, M10120426, M10120321, M10120208, M10111208, M10120510, M10120419, M10120317, M10120207, M10111201, M10120507, M10120413, M10120315, M10120130, and M10111028.
The product was distributed worldwide, including the United States (nationwide), Puerto Rico, Australia, Canada, and Lebanon. Healthcare facilities and users should stop using the affected tip covers and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 11,121
Distribution
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