Recall Z-0439-2013 ยท LKF Cannula, Manipulator/Injector, Uterine
Cooper Surgical, Inc.
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 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
| Date | Nov 26, 2012 (initiated Oct 31, 2012) |
| Status | Terminated |
| 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 |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932115 | ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI Blairden Precision Instruments, Inc., Jun 24, 1994 |