Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
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 involves a medical device with a potential for damage during use, which poses a risk of harm in a surgical setting, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 5,217 units of the 5X300 MM Curved Cannula, Arm 1, intended for use with the da Vinci Si Surgical System (model IS3000). The recall was initiated because the company became aware of the potential for certain lots of these Single-Site 5mm Curved Cannulae to become damaged during use.
The affected products are distributed worldwide, including in the United States and 22 other countries. The recall includes specific part number 428061-03 and a list of 31 specific lot numbers. The second part of this action involves updating Single-Site labeling to instruct users on how to inspect cannulae prior to use and to appropriately handle them during use.
These instruments are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue during single incision laparoscopic procedures. Users should inspect the cannulae prior to use and follow the updated handling instructions provided in the labeling changes.
The recalled product
- Product
- 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 5,217
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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