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

Catalog Number 60-6085-202

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/11/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that the patient had a robotic laparoscopic supracervical hysterectomy performed on (b)(6)-2014.Reportedly, the cervical cup of the vcare uterine manipulator was sutured in place as part of the preparation prior to the surgery.The procedure was completed as planned with no complications or problems noted.The patient was seen in the physician's office 2 weeks post operatively for routine follow-up and patient's status was ok (at time of office visit).However, it was further reported that the physician's office was later notified by the patient that at 6 weeks post-operative, the patient felt that "something wasn't right".This prompted her to seek medical care from one of the urgent care facilities.Examination revealed the green cervical cup of the vcare device was unknowingly left in the patient allegedly during the original surgery on (b)(6)-2014.The green cervical cup was removed and disposed of at the urgent care visit.As reported, there were no problems reported and no surgical intervention required.The risk management of the physician's facility confirmed that there was no patient injury.To date, there has been no additional information received indicating that any long term adverse effect has occurred.

Manufacturer Narrative

The "used/damaged" vcare uterine manipulator from the original surgery on (b)(6)-2014, nor the alleged unintended retention of a foreign object known as cervical cup that was reportedly removed during the urgent care visit are expected for evaluation, as they were presumably discarded at the user facilities.Without the actual device, an evaluation could not be performed and the alleged incident therefore could not be verified.A review of the device history record could not be performed as the lot number was not provided.A 2-year review of product history for this device family showed only one (1) other report of the cervical cup was left in the patient that required a second surgery to remove the foreign object.To date, there has been no patient long term adverse effect 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.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.Device discarded by end-user facility.

• 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: 4088511
• MDR Text Key: 4763842
• Report Number: 1320894-2014-00089
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Weight: 77