MAUDE Adverse Event Report: CONMED CORPORATION VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, LARGE; VCARE UTERINE MANIPULATOR

Catalog Number 60-6085-202

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

It was reported to conmed that, " balloon tip came off fell into abdominal cavity." it was also reported that the device fragment was retrieved and that there was no patient injury.

Manufacturer Narrative

This is an fda reportable event due to a sentinel event reported on medwatch 1320894-2012-00099.The actual device return is anticipated; however, the device has not been received at conmed to date.On completion of the quality engineering investigation of this reported incident a supplemental report will be filed.Device not yet returned to conmed corp.

Manufacturer Narrative

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 for lot 1310041 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.The actual device was returned by the end-user facility and a device evaluation was conducted.All device components were present as received, but the intrauterine balloon, cervical cone, and vaginal cone were completely detached from the manipulator tube.The pilot balloon check valve, handle, and manipulator tube were intact.In appeared that the intrauterine balloon and the cervical cone were pulled off forcefully.Examination of the distal end of the manipulator tube showed a small piece of the intrauterine balloon was still attached and there was sufficient application of adhesive, indicating that the intrauterine balloon had been securely attached.The diameter of the center hole in the large cervical cone measured within specifications.The outside diameter of shrink band provided an interference fit between the hole diameter of the cervical cone with the outside diameter of the shrink band on the manipulator tube.The intrauterine balloon adds additional resistance to detachment of the cervical cone.It was noted that there was damage to the distal portion of the cervical cone.No product defects were identified during the examination.Evidence suggests the cause of this complaint is application of force during manipulation of the device which exceeded the pull off strength capability of the cervical cone/intrauterine balloon.The risk associated with this complaint is mitigated in the dfu, directions 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 complaint investigation has not identified a manufacturing or component defect; therefore, corrective action is not warranted at the present time.Conmed corporation is considering this complaint closed.

• Brand Name: VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, LARGE
• Type of Device: VCARE UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer Contact: stephen casanova, rn, mps ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3590152
• MDR Text Key: 4031343
• Report Number: 1320894-2014-00009
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 1310041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1