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

Catalog Number 60-6085-200

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/29/2013

Event Type  Injury  

Event Description

It was reported, " unintended retention of a foreign object, rfo, - occurred (b)(6) 2011 during an abdominal hysterectomy, robot assisted laparoscopic and pelvic lymph node dissection.The retained foreign object was incidentally identified during an unrelated issue via ct scan on (b)(6) 2013.The rfo was identified and removed at a hospital in (b)(6) by choice of the patient.The piece was identified as the green cervix cup referenced as ref (b)(4) (vaginal-cervical-ahluwalia's-retractor-elevator).I do not have the status of the patient as she moved 3 days after the discovery of the rfo and did not give us the opportunity to remove it as i stated above, she did have it removed at another hospital.(surgically removed).

Manufacturer Narrative

The is being filed with the fda due to a retained device fragment.The device has been discarded by the end-user facility; therefore, an evaluation of the suspect device will not be accomplished.On completion of a quality engineering evaluation a supplemental report will be filed.Device discarded by end-user.

Manufacturer Narrative

As reported, neither the "used/damaged" vcare uterine manipulator from the original surgery on (b)(6) 2011, nor the alleged unintended retention of a foreign object known as cervical cup that was discovered on ct scan on (b)(6) 2013 and reportedly removed at a different hospital facility 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 complaint history for the time frame from (b)(6) 2011(original surgery date) to (b)(6) 2013 (date alleged foreign object discovered) showed that there were no complaints received from the user facility for any type of problems related to the device breakage and/or performance/usage of this device during the original surgery.In addition, even though the alleged unintended retained foreign object was discovered on (b)(6) 2013, this complaint/allegation was not received from the user facility until (b)(6) 2014.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 forty (40) similar reports for component detachments.(b)(4).It should be noted, of the 40 reports of component detachments, this reported incident is the only instance in which a second surgery was performed 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 for 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: intrauterine balloon, cervical cup, vaginal cup, locking assembly, and thumbscrew) have all been retrieved from the patient.Corrected data: the date of this report was reported improperly on the initial submission of this medwatch and the correct date is 4/18/2014, as reflected in this report.Also the initial report was submitted as a malfunction and should have been reported as a serious injury due to the second surgery.This correction is reflected in this report.

• Brand Name: VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, SMALL
• 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: 3805634
• MDR Text Key: 16222899
• Report Number: 1320894-2014-00053
• 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,Followup
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2014
• 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