Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments
Intuitive Surgical is recalling 8,217 Maryland Dissector instruments 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Intuitive Surgical, Inc. is recalling 8,217 units of the Maryland Dissector used with the da Vinci Si Surgical System (IS3000). The affected model numbers are 428050-12, 428050-13, and 428050-14, and the recall includes all lots. These instruments are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, and dissection during single incision laparoscopic cholecystectomy.
The recall was initiated because, in certain circumstances, the jaws of the grip actuated instruments may become fixed in a closed position. The agency has classified this as a Class II recall. The products 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.
Healthcare facilities and users of the da Vinci Si Surgical System should stop using the affected instruments and contact Intuitive Surgical for further instructions on the recall.
The recalled product
- Product
- Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 8,217
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)
- Model numbers: 428050-12. 428050-13 and 428050-14
- 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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