BEUDAMED
    FDA Enforcement Class II 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 · Reported December 5, 2012

    Enforcement

    Recall Number
    Z-0440-2013
    Event ID
    63681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cooper Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 5, 2012
    Initiation Date
    October 31, 2012
    Classification Date
    November 26, 2012
    Termination Date
    March 4, 2014
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    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

    Code Info

    Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069

    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