Intuitive Surgical Recalls Large Clip Applier Instruments Due to Jamming Risk
Intuitive Surgical is recalling Large Clip Applier instruments used with da Vinci S and SI systems because a manufacturing defect may cause the instrument to jam during insertion.
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, and the hazard involves a mechanical failure (jamming) during a surgical procedure, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems. The recall affects 5,290 units of part number 420230-04 and 1,964 units of part number 420240-06. These instruments were distributed worldwide.
The recall is due to a manufacturing variation in the grip assembly that can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories. The affected products were manufactured after May 16, 2014, and include specific lot and batch numbers listed in the agency's recall record.
Healthcare facilities and users should stop using the affected instruments and contact Intuitive Surgical for further instructions on the recall process.
The recalled product
- Product
- Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
- Manufacturer
- Intuitive Surgical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All product manufactured after May 16
- 2014 with lot numbers starting with M10120516. Part number 420230-06
Distribution
Distribution scope not specified by the agency.
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