PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: August 20, 2014 Initiated: June 2, 2014 #Z-2171-2014

Product Description

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).

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

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
2
Distribution
Distribution to Florida and South Carolina
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by Intuitive Surgical, Inc.. Units affected: 2.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2014. Severity: Moderate. Recall number: Z-2171-2014.

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