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

Catalog Number 60-6085-202

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2013

Event Type  malfunction  

Event Description

It was reported to conmed that, "handle separated from the cup - additional information from customer - when it came time to remove the v-care, the cup portion of the device detached and went into the pelvic cavity.The piece was retrieved." it was also reported 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 has been received from the end-user facility on (b)(6) 2013.The quality engineering evaluation has not yet commenced.On completion of the quality engineering investigation of this reported incident a supplemental report will be filed.

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 1308131 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.The cervical cone was completely detached from the manipulator tube as received.The blue vaginal cone was positioned at the distal end of the manipulator tube, over the intrauterine balloon.The locking mechanism was securely locked onto the manipulator tube.The locking mechanism was released and a mark on the manipulator tube was underneath the set screw, indicating the locking mechanism had not been released.The pilot balloon check valve and handle were intact.The blue vaginal cone was removed and the diameter of the hole at the distal end of the blue vaginal cone measured within specifications using calibrated pin gages.The diameter of the center hole in the cervical cone also measured within specifications.The intrauterine balloon appeared to have been pushed back toward the handle as if the blue vaginal cone had been forcefully pushed back onto the manipulator handle.The intrauterine balloon was removed and there were no pieces missing from the balloon.The outside diameter of shrink band was measured and provided an interference fit between the inside diameter of the cervical cone with the outside diameter of the shrink band on the manipulator tube.Application of adhesive on the manipulator tube appeared adequate where the intrauterine balloon was attached.The intrauterine balloon adds additional resistance to detachment of the cervical cone.No product defect was identified during the examination.Evidence suggests the cause of this complaint is application of force during manipulation of the device which exceeded its 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.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: intrauterine balloon, cervical cup, vaginal cup, locking assembly and thumbscrew) have been retrieved from the patient." the associated root cause cannot be conclusively determined from the available information; therefore, this complaint is considered inconclusive.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: 3558838
• MDR Text Key: 4054008
• Report Number: 1320894-2014-00002
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 1308131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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