Recall Z-0702-2022 · NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
| Date | Dec 23, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 12/23/21 recall notices were mailed to customers who were asked to do the following: 1. Inform necessary hospital personnel about this issue. 2. Locate all affected devices at your site and return to the recalling firm. 3. Inform affected personnel when the requested actions have been completed. 4. Complete and return the attached Acknowledgement Form 5. Please retain a copy of this letter and the acknowledgement form for your files. If you need further information or support contact your Clinical Sales Representative or contact Intuitive Customer Service: North and South America: (800) 87 |
| Quantity | 149,646 reducers |
| 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, Nebr |
| FDA record | Open on fda.gov |