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Recall Observatory FDA recall evidence

Device product

da Vinci Si Surgical System IS3000, Camera Head 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-1385-2015

March 16, 2015

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 70777
Status
Terminated
Classification
Class II
Quantity
442,475 total all drape models
Official record key
device-enforcement:Z-1385-2015

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 420273-02; da Vinci Si Camera Head Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

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

    reason.no_named_rule · v1.0.0

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