MAUDE Adverse Event Report: CONMED UTICA VCARE 200A - MEDIUM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number 60-6085-201A

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2022

Event Type  Injury  

Event Description

The customer reported that the device 60-6085-201a, vcare 200a - medium, was being used during a robotic hysterectomy procedure on (b)(6) 2022 when it was reported that ¿vcare device fell apart into 3-4 pieces inside the patient's body." the procedure was completed without the use of an alternate device and there was no delay reported.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of surgical, medical intervention, or hospitalization for the patient.This report is being raised on the basis of injury due to possible retained device.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device 60-6085-201a, vcare 200a - medium, was being used during a robotic hysterectomy procedure on (b)(6) 2022 when it was reported that ¿vcare device fell apart into 3-4 pieces inside the patient's body." the procedure was completed without the use of an alternate device and there was no delay reported.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of surgical, medical intervention, or hospitalization for the patient.This report is being raised on the basis of injury due to possible retained device.

Manufacturer Narrative

The reported event of ¿device fell apart inside the patient¿ is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A 2 year lot history review was conducted and found 2 events for this lot number and failure mode.A dhr review found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 144 complaints, regarding 179 devices, for this device family and failure mode.During this same time frame 550,400 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0003.Per the instructions for use, the user is advised to re-attach the syringe to the luer connector at the end of the pilot balloon; fully aspirate the air from the intrauterine balloon to deflate.This will allow the intrauterine balloon to be removed from the uterus.Unlock the locking mechanism by turning the thumbscrew counter-clockwise (anti-clockwise) and retract to the handle.Swipe finger around the edge of the vaginal cup to separate tissue from the cup to prevent tissue damage.Fully retract the vaginal cup to the handle.Carefully remove the device form the vagina.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal.Upon removing the vcare, the surgeon should visually inspect the vcare device and the patient to ensure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: VCARE 200A - MEDIUM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15472109
• MDR Text Key: 300558981
• Report Number: 1320894-2022-00196
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)240424(10)202204251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202204251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic