Intuitive Surgical, Inc.: 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

Hazard

Potential staple deployment failure and device fragment generation

Details from the source

Reason for recall: Potential staple deployment failure and device fragment generation Distribution: U.S.: 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. O.U.S.: None Quantity: 160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads Lot/code info: Model Name / Model Number / UDI-DI Code: Da Vinci Xi 8mm SureForm 30 instruments 488530-10 10886874121723 Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-02 10886874121938 Da Vinci Xi 8mm SureForm 30 White Reload 48230W-02 10886874121921 Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-02 10886874121914 All Serial Numbers

UPC codes

10886874121723, 10886874121938, 10886874121921, 10886874121914

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.