Recall Z-0404-2018 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be
| Date | Sep 19, 2017 |
| Status | Terminated |
| Reason | Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument. |
| Root cause | Process control |
| Action | The firm initiated their recall by email on 09/19/2017 and followed with a letter delivered by FedEx on 09/20/2017. The notice requested the following actions: "Please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who are involved with da Vinci procedures. 1.Using the lot numbers listed above, please locate and return all affected Staplers at your site via the standard RMA process. a. Credit will |
| Quantity | 60 units |
| Distribution | US Nationwide Distribution |
| 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 |