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

Catalog Number 60-6085-203

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/18/2013

Event Type  malfunction  

Event Description

It was reported to conmed that, " the v-care manipulator was removed from the patient without extreme forces.It was noted on post-operative day two, that the green cup attached to the v-care manipulator become detached and was retained in the patient's vagina." 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 discarded by the end-user facility at the end of the original surgery and is not available for evaluation.On completion of the quality engineering investigation of this reported incident a supplemental report will be filed.Device not being 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 dhr/lhr, device history record/lot history record, review was not accomplished as the lot number of the device was not made available.The device was discarded by the end-user facility; therefore, a device evaluation was not conducted.The reported failure cannot be confirmed and the specific failure mode as well as associated root cause cannot be conclusively determined without examination of the actual device.Therefore, this complaint is considered inconclusive.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: 1.Intrauterine balloon, 2.Cervical cup, 3.Vaginal cup, 4.Locking assembly and 5.Thumbscrew) have been retrieved from the patient." the complaint investigation could not confirm or identify the specific failure mode or root cause without examination of the actual complaint device; therefore, corrective action is not recommended as a result of this complaint.Conmed corporation is considering this complaint closed.Not returned to conmed.

• 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 ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3583731
• MDR Text Key: 4140552
• Report Number: 1320894-2014-00006
• 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: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/07/2014

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 Catalogue Number: 60-6085-203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2014
• 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 Age: 50 YR
• Patient Weight: 80