Intuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure
Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.
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: This is a Class II medical device recall of surgical instruments with potential for serious harm during use. However, the source text does not report any injuries or illnesses, and the hazard is characterized as 'potential.' Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Intuitive Surgical, Inc. is recalling specific models of Da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads used in minimally invasive surgery. The recall affects 960 individual instruments and 7,224 reloads distributed across 23 U.S. states.
The devices are being recalled due to potential staple deployment failure and device fragment generation. These defects could occur during surgical procedures and compromise the intended function of the instruments.
The affected products were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. The FDA has not received reports of patient injury or illness related to this issue.
Healthcare providers should immediately cease use of affected instruments and reloads. Facilities should contact Intuitive Surgical for instructions on device return or replacement.
The recalled product
- Product
- INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- staple-deployment-failure
- device-fragment
Distribution
Distribution scope not specified by the agency.
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