News
- CareFusion Provides Update on Voluntary Recall of Neurological Monitoring Software and Devices
- Covidien Contraindicates the Use of Duet TRSTM for Thoracic Surgery, Implements a Voluntary Recall
- Intuitive Surgical 4Q profit rises 25 percent
CareFusion Provides Update on Voluntary Recall of Neurological Monitoring Software and Devices
SAN DIEGO, Jan. 20, 2012 /PRNewswire/ --CareFusion issued the following update regarding its voluntary recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The FDA has classified this action as a Class I recall.
The company initiated the voluntary recall, which affects 125 devices and 58 software licenses, in October 2011. The devices and software subject to the recall were distributed to 38 customers between May 7, 2009 and July 11, 2011. This action has no effect on the manufacture or distribution of current products.
There is no change to the remediation plan previously communicated by the company. CareFusion has already completed the majority of the corrective actions on affected products in the United States.<\p>
In October 2011, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. Affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the Cortical Stimulator Control Unit screen and in the associated report. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.
Covidien Contraindicates the Use of Duet TRSTM for Thoracic Surgery, Implements a Voluntary Recall
MANSFIELD, Mass.--(BUSINESS WIRE)-- Covidien, a leading global provider of healthcare products, today announced that it is conducting a voluntary recall of all production lots for the Duet TRSTM Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery.” .
Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. The Company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.
Covidien is working with the United States Food and Drug Administration (FDA) and other worldwide regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Further, the Company placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use. Additionally, it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.
“These steps are consistent with our belief that patient safety is a commitment that cannot be compromised,” said Hanson. “Patient safety is our first obligation.”
Launched in 2009, the Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 500,000 units worldwide. Covidien believes approximately one-third of global procedures using Duet TRS are for thoracic indications. The Duet TRS will continue to be used for other indications, including abdominal procedures.
Intuitive Surgical 4Q profit rises 25 percent
Associated Press – Thu, Jan 19, 2012
SUNNYVALE, Calif. (AP) -- Intuitive Surgical Inc.'s fourth-quarter profit climbed 25 percent in the fourth quarter on greater sales and service revenue for its da Vinci robotic surgical system.
The results solidly beat expectations, but shares of the medical equipment maker fell in after-hours trading. The stock had risen more than 50 percent over the past year because of the company's rapid growth and history of beating estimates..
The medical equipment maker said Thursday that its profit grew to $151.2 million, or $3.75 per share, from $121.2 million, or $3.02 per share. Revenue increased 28 percent to $496.8 million from $389.3 million last year. .
The company said it sold 152 da Vinci systems during the quarter, up from 124 a year earlier, and procedures performed with its systems grew 27 percent.
Intuitive Surgical said its revenue from instrument and accessories sales grew 30 percent to $196.4 million. System revenue rose 27 percent to $225 million and service revenue increased 24 percent to $75.4 million.
For all of 2011, profit rose 30 percent, to $495 million, or $12.32 per share, from $382 million, or $9.47 per share, in 2010. Its revenue grew 24 percent, to $1.76 billion from $1.41 billion.