Recalls / —
—#128783
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).
- FDA product code
- NAY — System, Surgical, Computer Controlled Instrument
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K113706
- Affected lot / code info
- Model number 410298-05 and 410298-06
Why it was recalled
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 (FDA determination)
Labeling Change Control
Action the firm took
Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..
Recalling firm
- Firm
- Intuitive Surgical, Inc.
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304
Distribution
- Distribution pattern
- Distribution to Florida and South Carolina
Timeline
- Recall initiated
- 2014-06-02
- Posted by FDA
- 2014-08-08
- Terminated
- 2014-08-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #128783. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.