FDA Recall Terminated

KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

Recall: Z-2104-2012 · Initiated July 13, 2012

Recall

Recall Number: Z-2104-2012
Event Number: 62553
Firm: Intuitive Surgical, Inc.
FEI Number: 3001675293
Product Code: NAY
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: July 13, 2012
Posted: July 27, 2012
Terminated: June 12, 2013
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

Description

Reason

Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

Action

Intuitive Surgical sent an Urgent Medical Device Correction letters dated July 16, 2012 via Fed Ex to all affected customers in the US. The customers outside of the US were notified starting July 17, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to Identify affected lots, order replacement products and return both full and partial boxes of the affected products for credit as soon as unaffected products are available. All staff should be made aware of the issue. Customers were instructed to complete and return the acknowledgement form immediately. Questions and concerns should be directed to Intuitive Customer Service at 1-800-876-1310. EXPANSION: Intuitive discovered an additional lot (Lot DA121075) of Instrument Arm Drape IS2000, 20 pack that should have been included in the recall and expanded the recall on September 4, 2012. Letters to customers were sent by Fed Ex on September 5, 2012.

Distribution

Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

Quantity

92390 total instrument Drapes