Device product
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 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.
Z-1388-2015
Product summary
- Event
- Event 70777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 442,475 total for all drape models
- Official record key
device-enforcement:Z-1388-2015
Official wording
Reason: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Code information: Product number 420022-02; da Vinci S Camera Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142205, D142205A, D142275, D142275A, D142315, D142325, D142335, D142345, D142345A, D142375, D142375A, D142385, D142485, D142625, D142625A, D142655, D142685, D142695, D142695A, D142765, D142765A, D142835, D142835A, D142905, D142905A, D142965, D142975, D143015, D143035, D143035A, D143105, D143115, D143175, D143175A, D143185, D143245, D143255, D143255A, D143315, D143315A, D143385, D143385A, D143445, D143445A, D143515, D143515A, D150085, D150085A, D150095, D150155, D150155A, D150215, D150215A, D150295, D150295A, D150355, D150365, D150365A, D150425, D150435, D150435A, D150515, D150515A, D150565, D150575, D150575A, D150645, D150655, D150655A, DA142625, DA142835, DA143315, DA143385, DA150295, DA150515
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.
Derived failure modes
-
Unknown
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.