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

Catalog Number 60-6085-202

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported, "the v-care uterine manipulator broke into pieces while in use." it also was reported that all pieces were retrieved without injury.

Manufacturer Narrative

This event is being reported due to a sentinel event reported on medwatch 1320894-2012-00099.The device return is anticipated; however, has not been received at conmed corporation to date.A supplemental report will be submitted on completion of the quality engineering evaluation.

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 1208271 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 is reported on the end-user submitted medwatch was returned to the manufacturer on 12 february 2014.The actual device from the incident was never received at conmed corporation from the end-user facility; therefore, a device evaluation was not conducted.The complaint device was not available for evaluation.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 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.Not returned to conmed.

• Brand Name: VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR
• 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: 3670663
• MDR Text Key: 4243268
• Report Number: 1320894-2014-00022
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 1208271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• 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