MAUDE Adverse Event Report: CONMED CORPORATION VCARE SMALL (31MM CUP); UTERINE MANIPULATOR

Catalog Number 60-6085-200

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

The "damaged/used" vcare uterine manipulator was not returned for evaluation of "vcare was used on patient and upon removing device from the patient's uterus it broke into 3 pieces." however, photographs of the device were provided which show that the cervical cone and vaginal cone had completely detached from the device.Therefore, this complaint is confirmed it is noted that the intrauterine balloon appeared to be intact and remained attached to the device, along with the locking mechanism, handle and pilot balloon.The cause of this complaint cannot be conclusively determined without examination of the complaint device.However, based on the information received and photographic evaluation, this complaint may be use related.The device was manufactured 08-feb-2016.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed 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.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.Methods should be used to reduce the size of the uterus prior to removal through the vaginal canal.-visually inspect the vcare device on removal from 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.

Event Description

As reported by the user facility, during a laparoscopic abdominal hysterectomy on b)(6) 2017 a "vcare was used on a patient and upon removing device from the patient's uterus it broke into three (3) pieces." further information from the facility revealed that the vcare came apart at the end of the procedure as they were removing the uterus from the patient."the green cup detached and was inside the patient.The surgeon retrieved the green cup from inside the patient." all three (3) pieces were retrieved and verified by the surgeon.There was no patient injury or surgical delay.This incident is being reported based on the potential for injury with recurrence.

• Brand Name: VCARE SMALL (31MM 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: 6279985
• MDR Text Key: 65854216
• Report Number: 1320894-2017-00014
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00653405061796
• UDI-Public: (01)00653405061796(17)18020(30)1(10)201602081
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2017

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: 02/07/2018
• Device Catalogue Number: 60-6085-200
• Device Lot Number: 201602081
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR