Recall Z-2105-2012 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,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.
| Date | Jul 27, 2012 (initiated Jul 13, 2012) |
| Status | Terminated |
| Reason | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Root cause | Nonconforming Material/Component |
| 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 acknowledgeme |
| Quantity | 92390 total instrument Drapes |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |