MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.

Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.

Product as listed by the FDA

5X250 MM Curved Cannula, Arm 2 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) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

Where it was distributed

Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.