Class 2 Device Recall Cooper Surgical Advincula Arch

• Date Initiated by Firm: October 31, 2012
• Date Posted: November 26, 2012
• Recall Status: Terminated on March 04, 2014
• Recall Number: Z-0440-2013
• Recall Event ID: 63681
• 510(K)Number: K932115
• Product Classification: Cannula, manipulator/injector, uterine - Product Code LKF
• Product: Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
• Code Information: Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
• Recalling Firm/ Manufacturer: Cooper Surgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Customer Service; 203-601-9818
• Manufacturer Reason for Recall: Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
• FDA Determined Cause: Device Design
• Action: CooperSurgical issued notification on October 31, 2012, to all affected customers Fed X . The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return units for replacement. Customers with questions should contact Customer Serivce at 1-203-601-9818 or 800-243-2974. Customers were asked to fill out the attached Replacement of Recalled Product Form and fax it to 1-800-262-0105. For questions regarding this recall call 203-601-9818.
• Quantity in Commerce: 1215 total
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.
• 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 = LKF