Report number (b)(4) was found on the fda maude database stating, "vcare uterine manipulator (medium size) was in use during a robotic hysterectomy.At the completion of the uterine manipulation an attempt to remove the vcare resulted in the device separating into four pieces.The upper and lower cups and tube were retrieved without difficulty.A small plastic connector however was difficult to locate but was eventually retrieved." the maude report stated that this was a product problem report and not an adverse event report; therefore, based on the information available to conmed corporation, no patient injury occurred.The maude report does not have any end-user facility documented, or, any contact information; therefore, conmed is unable to obtain any further information surrounding this reported event.
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This is an fda reportable event due to a sentinel event reported on medwatch 1320894-2012-00099.The device is unable to be returned to conmed corporation for this event was discovered on the fda maude database.The end-user facility or any contact information has not been documented on the maude report and it is impossible to contact the end-user facility; therefore, an investigation on the suspect device will not be conducted.The device in question, vcare, is a disposable, single-use device for manipulation of the uterus and cervix in surgical and diagnostic procedures.The device consists of a manipulator tube having an inflatable balloon at its proximal end and an anatomically configured cannula / handle for maintaining proper attitude of the uterus at the distal end.The vcare incorporates a system of cup-like elevators to provide manipulation of the uterus, and retraction and elevation of the cervix.The conmed vcare is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (lavh), total laparoscopic hysterectomy (tlh), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once a colpotomy is performed.A review of the manufacturing documents from the dhr/lhr, device history record/lot history record, for lot 1310141 has verified the devices were produced and released according to the current and approved procedures and material specifications.Proper manufacturing procedures including testing and inspections were performed during manufacture to prevent non-conformances regarding the product's identity, quality, safety, effectiveness and performance.A potential cause of this complaint is application of force during manipulation of the device which exceeded the cervical cone pull off strength capability.A contributing factor may have been not unlocking the locking mechanism and retracting the vaginal cone prior to removal of the device.This factor would increase resistance allowing the vcare shaft to pull through the cervical cone.The risk associated with this complaint is mitigated in the ifu, instructions for use, which states, "prior to removal of the device, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.Vaginal delivery of a large uterus may result in patient injury.Morcellation or other methods should be used to reduce the size of the uterus prior to removal through the vaginal canal.Visually inspect vcare on removal from the patient to verify that the device is intact and all forward components (figure #1: 1.Intrauterine balloon, 2.Cervical cup, 3.Vaginal cup, 4.Locking assembly and 5.Thumbscrew) have been retrieved from the patient." the device was not returned for evaluation and the incident is most probably end-user related.The complaint investigation has not identified a manufacturing or component defect and the malfunction has been determined as use related; therefore, corrective action is not warranted at the present time.Conmed corporation is considering this complaint closed.Device not yet returned to manufacturer.
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