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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).

FDA Recall Z-2171-2014 · Posted 2014-08-08

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2014-06-02
Date Terminated2014-08-08
Product Quantity2

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

Firm Action

Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..

Root Cause

Labeling Change Control

Distribution Pattern

Distribution to Florida and South Carolina

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113706ENDOWRIST STAPLER SYSTEMIntuitive Surgical, Inc. · 2012-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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