BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0440-2013 · Initiated October 31, 2012

    Recall

    Recall Number
    Z-0440-2013
    Event Number
    63681
    Firm
    Cooper Surgical, Inc.
    FEI Number
    1216677
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 31, 2012
    Posted
    November 26, 2012
    Terminated
    March 4, 2014
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    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

    Reason

    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

    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.

    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.

    Quantity

    1215 total