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 05/28/2015

Event Type  No Answer Provided  

Event Description

On 06-jul-2015, conmed received the user voluntary medwatch report #(b)(4) forwarded by the fda.Listed below is the incident description based on the provided information on the medwatch report as well as the additional follow-up information from the user facility.The user facility reported that during use of the vcare uterine manipulator on (b)(6) 2015 in a laparoscopic hysterectomy procedure, the vcare green ring and balloon tip became dislodged from the manipulator while removing the uterus.As reported, the green ring was removed manually without incident and the balloon tip was found on the floor.Follow-up with the end user facility confirmed that the procedure went on with the use of a second device and was completed as intended with no further complications or serious injury to the patient.To date, there has been no additional information received regarding the patient's latest condition or indication that any long term adverse effect has occurred.

Manufacturer Narrative

The "used/damaged" vcare uterine manipulator from the surgery on (b)(6) 2015 was returned to conmed for evaluation.Visual inspection found the intrauterine balloon and cervical cups had detached from the manipulator tube.The intrauterine balloon was deformed, indicating that it had been forcefully detached when the cervical cup as pulled over the shrink band.There appeared to have been an adequate amount of adhesive applied to the area of the manipulator tube where the intrauterine balloon was attached.The intrauterine balloon adds additional interference and resistance to detachment of the cervical cup.Measurement of the returned components confirmed all dimensional were within specifications and no product defects were identified during examination.In this instance, evidence suggests that the most likely cause of this reported problem is user error for not releasing the "locking mechanism" of the device and/or application of force during manipulation of the device which exceeded the pull off strength of the cervical cup/intrauterine balloon.This device was manufactured 16-feb-2015.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident.Of the lot containing (b)(4) units, there were no other similar complaints received.A 2-year review of product history for this device family showed a total of (b)(4) similar reports of vcare component separation inside the patient.During this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4).It should be noted, of the (b)(4) reports of component detachments, there has been only (b)(4) report in which a second surgery was performed to remove the retained foreign objects.To date, there have been no patient long term adverse effects reported regarding any of the reported incidents.The vcare uterine manipulator 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.It should be noted that the end-user facility reported that "the vcare green ring and balloon tip became dislodged from the handpiece while removing the uterus".Based on this received information, it is believed that the reported incident is user related due to misuse of the device, as removal of the specimen (uterus) is not one of the documented indications for this device.To reduce the risk of component detachment and patient injury, the instruction for use (ifu) provides the following warnings and precautions: 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 all been retrieved from the patient.

• 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: vickie ingle ; 525 french rd; utica, NY 13502 ; 3156243053
• MDR Report Key: 4950098
• MDR Text Key: 6033295
• Report Number: 1320894-2015-00022
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 1502161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR