FDA recall Z-0702-2022

Intuitive Surgical, Inc. · Class II · device

Product

da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

Reason for recall

Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.

Distribution

Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebraska, Maryland, Oklahoma, Colorado, Arkansas, Arizona, Kansas, Illinois, South Carolina, Minnesota, North Dakota, Iowa, Louisiana, Washington, Delaware, Mississippi, New Mexico, District of Columbia, Idaho, New Hampshire, Rhode Island, West Virginia, South Dakota, Alaska, Maine, Utah, Montana, Vermont, Wyoming, Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Monaco, Netherlands, Norway, Poland, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2021-12-23
Report date
2022-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0702-2022