Recall Z-2171-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or syntheti
| Date | Aug 8, 2014 (initiated Jun 2, 2014) |
| Status | Terminated |
| Reason | Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic |
| Root cause | Labeling Change Control |
| Action | Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites.. |
| Quantity | 2 |
| Distribution | Distribution to Florida and South Carolina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113706 | ENDOWRIST STAPLER SYSTEM Intuitive Surgical, Inc., Oct 17, 2012 |