—#134707

Product

da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA product code: KKX — Drape, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K050322
Affected lot / code info: Product number 420256-01; da Vinci S Disposable Accessory Kit, 3 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers numbers for Tear issue: D142205, D142275, D142345, D142375, D142625, D142695, D142765, D142835, D142905, D142975, D143035, D143115, D143175, D143255, D143315, D143385, D143445, D150085, D150215, D150295, D150365, D150435, D150515, D150575, D150655

Why it was recalled

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Root cause (FDA determination)

Packaging process control

Action the firm took

Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

Timeline

Recall initiated: 2015-03-16
Posted by FDA: 2015-04-06
Terminated: 2015-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.