Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.
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 is classified as FDA Class II. The hazard involves a functional failure (firing failure) of a surgical device, which poses a risk of harm during surgery, but the source text does not report specific injuries or hospitalizations, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads, model number 470530. These devices are intended for use with the da Vinci Xi Surgical System (Model IS4000) for resection, transection, and creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery for adult and pediatric patients.
The recall was initiated because of an increase in customer complaints regarding a 'Stapler Firing Failed' message. Additionally, a review of da Vinci Xi Surgical System logs revealed an increased trend of these firing failures. The recall covers 2,065 units distributed in the United States, Puerto Rico, Australia, and various international locations including Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
Healthcare providers and facilities should stop using the affected devices and contact Intuitive Surgical for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or cr
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,065
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 (1)
- All
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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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