Recall Z-2380-2018 ยท GDW Staple, Implantable
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
| Date | Apr 23, 2018 |
| Status | Terminated |
| Reason | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired. |
| Root cause | Nonconforming Material/Component |
| Action | Intuitive Surgical, Inc. (ISI) conducted the recall and notified customers via letter "Field Safety Notice Urgent Medical Device Notification" sent the week of April 23, 2018. The letter notified customers of the recall, reason for field action, risk to health, affected products, Actions to be taken by the Customer/User, Actions to be taken by Intuitive Surgical, and Further Information and Support: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numb |
| Quantity | 7337 |
| Distribution | U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140553 | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS Intuitive Surgical, Inc., Jul 25, 2014 |