Date Initiated by Firm |
June 02, 2014 |
Date Posted |
August 08, 2014 |
Recall Status1 |
Terminated 3 on August 08, 2014 |
Recall Number |
Z-2171-2014 |
Recall Event ID |
68814 |
510(K)Number |
K113706
|
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
|
Product |
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 synthetic). |
Code Information |
Model number 410298-05 and 410298-06 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
|
For Additional Information Contact |
Mark Johnson 408-523-2100
|
Manufacturer Reason for Recall |
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
|
FDA Determined Cause 2 |
Labeling Change Control |
Action |
Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites.. |
Quantity in Commerce |
2 |
Distribution |
Distribution to Florida and South Carolina |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
|