Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers
Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the potential for significant injury in a surgical context.
Plain-English summary
Intuitive Surgical, Inc. is recalling 6,309 units of the Fundus Grasper (Model numbers 428058-12 and 428058-13) used with the da Vinci Si Surgical System (IS3000). The recall covers all lots of these specific model numbers.
The recall was initiated because, in certain circumstances, the jaws of these grip actuated instruments may become fixed in a closed position. This defect could potentially interfere with the intended endoscopic manipulation of tissue during surgical procedures.
The affected instruments were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom. These instruments are indicated for use by trained physicians in an operating room environment for single incision laparoscopic cholecystectomy.
The recalled product
- Product
- Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 6,309
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 (3)
- Model numbers: 428058-12
- 428058-13
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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