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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the 60-6085-200a, small, uterine manipulator, vaginal, device was being used on (b)(6) 2025 during a hysterectomy procedure when it was reported ¿inflatable balloon on v-care found to be detached after removal of v-care intraoperatively.Paused surgical procedure to locate missing piece.All components of v-care were located before proceeding.Product disposed of upon completion of surgery.¿ the procedure was completed without the use of an alternate device and 30-minute delay was reported.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the 60-6085-200a, small, uterine manipulator, vaginal, device was being used on (b)(6) 2025 during a hysterectomy procedure when it was reported ¿inflatable balloon on v-care found to be detached after removal of v-care intraoperatively.Paused surgical procedure to locate missing piece.All components of v-care were located before proceeding.Product disposed of upon completion of surgery.¿.The procedure was completed without the use of an alternate device and 30-minute delay was reported.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event 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 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 13 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 that 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 6 forward components to the vcare cervical elevator retractor.1) intrauterine balloon, 2) cervical cup, 3) vaginal cup, 4) locking assembly, 5) thumbscrew, 6) heat shrink.We will continue to monitor per regulatory requirements to help ensure 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 22149028
• Report Number: 1320894-2025-00147
• Device Sequence Number: 15570579
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)260218(10)202402191
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2026
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202402191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic