Valtchev Uterine Mobilizer
Conkin Surgical Instruments Ltd · Model VUM-6 · UDI-DI 00627843701781
Description
THE VALTCHEV® UTERINE MOBILIZER, MODEL VUM-6 consists of a body and interchangeable obturators and cannulas. The body consists of a metal bar and a metal tube which pivot the head. One end of the tube is attached to a piston and the opposite end is attached to a Luer syringe connector. The locking wheel is also attached to the tube. The locking wheel is held in place by a lock. The arm space bar permits manipulation of the head. By means of a locking screw on the upper end of the arm space bar the Mobilizer can be locked in the desired position. The finger ring is located at the lower end of the arm spacer bar. The head accommodates, in its cavity, an obturator or a cannula locking in place by a lock. The four uterine obturators, which are of different lengths and thicknesses are used as follows: No.17 and No.18 are for mobilization of a smaller uterus, No.19 and No.20 are for mobilization of larger uterus. The cannulas: (15A) and (16A) are used for injection of either dye or an X-ray contrast medium. The syringe for injection is attached to the Luer syringe connector. The Mobilizer is held in place by a Valtchev® tenaculum, supported by a tenaculum holder and held taut by a spring. This device is reusable. The attachments have no stand alone functionality, however can be ordered separately.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay |
| 2019-05-30 | Clinical Innovations, LLC | An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result |
| 2015-05-18 | CooperSurgical, Inc. | Design of device may expose user to injury to fingers or body parts |
| 2014-07-03 | CooperSurgical, Inc. | Unsealed pouches. |
| 2014-05-13 | CooperSurgical, Inc. | Sterility of the device may be compromised due to unsealed pouch |
| 2012-10-31 | Cooper Surgical, Inc. | 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 |
| 2012-10-31 | Cooper Surgical, Inc. | 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 |
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