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

Catalog Number 60-6085-201

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 09/03/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that the patient had a total laparoscopic hysterectomy performed on (b)(6) 2014.During removal of the uterus, after the colpotomy was supposedly completed, the cervical cup of the vcare device was found detached and reportedly came off over the balloon at the distal tip of the device.Additional information received from the facility indicated that after the cervical cup was found detached, and once most of the uterus had been removed, the surgeon was then realized that a portion of the colpotomy surgical procedure had not been completed and that the cervix portion of the uterus approximately 1-2 cm of tissue was still holding it in place and was not completely excised from the patient.As reported, the cervical cup was retrieved and the procedure was completed with no further complications or patient injury.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 original surgery was returned to conmed for evaluation on (b)(4) 2014.Visual inspection found the cervical cup of the device was completely detached from the manipulator tube.The proximal end of the intrauterine balloon was pushed over the shrink band, which presumably occurred when the cervical cup was detached from the manipulator tube.The diameter of the center hole in the cervical cone measured within specifications.The outside diameter of the 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 regarding detachment of the cervical cone.Examination of the intrauterine balloon under a microscope found a tear or slit (approximately 1/16 inch) in the top middle of the balloon.Based on the overall findings, no product defects were identified during the evaluation of this returned "damaged" device.The surgeon reported that after the cervical cup of the device detached, it was noticed that the colpotomy portion of the surgical procedure had not been completed and the cervix portion of the uterus was not completely excised from the patient.Attempting to remove the uterus when the tissue of the uterus approximately 1-2 cm of tissue was still partially attached to the patient would increase the resistance during the attempted removal of the device.The application of force applied during the attempted removal of the device and uterine specimen most probably exceeded the pull off strength capability of the cervical cone/intrauterine balloon.This device was manufactured on 07-apr-2014.Of the lot containing 3,136 units, there were no other similar complaints received.A review of the device history record for this lot number found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported device detachment.A 2-year review of complaint history for this device family shows thirty-six (36) reports of cervical cup detachments.During this same time frame, over (b)(4) units were sold worldwide, making the rate of occurrence for this failure mode at (b)(4).It should be noted, of the 36 reports of component detachments, there has been only 1 report in which a second surgery was performed to remove the foreign objects.To date, there has been no patient long term adverse effect reported regarding any of these 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.To reduce the risk of component detachment and patient injury, the instruction foe 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, MEDIUM
• 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: 4148833
• MDR Text Key: 4928135
• Report Number: 1320894-2014-00093
• 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: Other
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 1404071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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: 38 YR
• Patient Weight: 79