MAUDE Adverse Event Report: CONMED UTICA VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number	60-6085-200A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-6085-200a, vcare 200a - small device was being used during an unnamed procedure on (b)(6) 2024, and ¿the blue cone portion of the uterine manipulator fell off during the procedure.It was discovered during the removal of the instrument.A vaginal tear was discovered and sutured by the surgeon.¿.The procedure was completed with a one-hour delay and without the use of an alternate device.The patient's status was reported as "discharged".This report is being raised due to the reported injury of a vaginal tear sutured by the surgeon.
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-6085-200a, vcare 200a - small device was being used during an unnamed procedure on (b)(6) 2024, and ¿the blue cone portion of the uterine manipulator fell off during the procedure.It was discovered during the removal of the instrument.A vaginal tear was discovered and sutured by the surgeon.¿.The procedure was completed with a one-hour delay and without the use of an alternate device.The patient's status was reported as "discharged".This report is being raised due to the reported injury of a vaginal tear sutured by the surgeon.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of (b)(4) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: 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.A.Swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage b.Fully retract the vaginal cup to the handle.Carefully remove the device from the vagina.Do not use excessive force to avoid traumatizing the vaginal canal.Upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.There are 5 parts/components to the vcare cervical elevator retractor.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: VCARE
• Common Device Name: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19817968
• Report Number: 1320894-2024-00182
• Device Sequence Number: 8694726
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)241016(10)202210171
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2024
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202210171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic