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

Catalog Number 60-6085-201

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

The "used/damaged" vcare uterine manipulator from the surgery on (b)(6) 2016 was not returned to conmed for evaluation.The reported failure cannot be confirmed and a specific failure mode as well as associated root cause cannot be conclusively determined without examination of the actual device.However, based on information from the user facility the device came apart "while attempting to remove the uterus from the patient using the vcare uterine manipulator." this suggests that this reported incident may be use related as removal of the specimen is not one of the documented indications for this device.The device was manufactured 8-aug-2016.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have led to this reported incident.Of the lot containing (b)(4) units, there were no other similar complaints received.(b)(4).To date there has been no patient long term adverse effects reported regarding any of the reported incidents.This type of failure mode is addressed in the risk documents and the safety risk has been found to be acceptable.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 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 ifu provides the following warning and precautions, as well as removal instructions: - prior to removal of the device, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge if the vaginal cup to separate the tissue form the cup to prevent tissue damage.- swipe finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Fully retract the vaginal cup from the handle.Carefully remove the device from the vagina.Do not use excessive force to avoid traumatizing the vaginal canal.- vaginal delivery of a lager 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 form the patient to verify that the device is intact and all forward components (intrauterine balloon; cervical cup; vaginal cup; locking assembly, and thumbscrew) have all been retrieved from the patient.Device discarded at facility.

Event Description

Conmed received a medwatch report from the user facility regarding a total laparoscopic hysterectomy on (b)(6) 2016.According to the report "while attempting to remove the uterus from the patient using the vcare uterine manipulator, the device came apart leaving pieces of the device inside the patient.Two cups came off and were retrieved under direct visualization of the laparoscope via vagina.All pieces were removed from the patient as well as the specimen.All pieces were evaluated and matched by staff." there was no surgical delay or patient injury and the patient was discharged home with no reported complications.Follow up with the user facility confirmed that the device was discarded at the hospital and thus not available for evaluation.The device was not reprocessed as was indicated on the medwatch report.To date no further information has been received regarding this incident.This report is being filed as a malfunction with the potential for injury with recurrence.

• Brand Name: VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR WITH MEDIUM CERVICAL CUP
• Type of Device: UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: kimber boss ; 525 french road; utica, NY 13502-5994 ; 3156243441
• MDR Report Key: 6174054
• MDR Text Key: 62529705
• Report Number: 1320894-2016-00153
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00653405061802
• UDI-Public: (01)00653405061802(17)180808(30)1(10)201608081
• 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 faci
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201608081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR