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

Catalog Number	60-6085-200A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-6085-200a, small, uterine manipulator, vaginal device was used in a tlvh procedure on (b)(6) 2025, and ¿balloon wasn't inflated and uterus was perforated¿.The procedure was completed without the use of an alternate device and a delay of 15 minutes.It was further reported that there was ¿no harm to patient", and the patient¿s status was "good".The customer did not respond to further questions upon request; therefore, it is unknown whether "balloon wasn't inflated" involved a device malfunction, user error, or other.This report is being raised due to the reported injury of a perforated uterus.
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.
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 one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of two reports, regarding four devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: check the pilot balloon frequently to ensure inflation of the intrauterine balloon.If the intrauterine balloon ruptures, the pilot balloon will not feel firm when squeezed between your fingers.If the intrauterine balloon has ruptured, stop all manipulation immediately, remove vcare and replace it with a new vcare unit.Use of a ruptured balloon eliminates the protection to the uterine wall and may increase the potential for uterine perforation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-6085-200a, small, uterine manipulator, vaginal device was used in a tlvh procedure on (b)(6) 2025, and ¿balloon wasn't inflated and uterus was perforated¿.The procedure was completed without the use of an alternate device and a delay of 15 minutes.It was further reported that there was ¿no harm to patient", and the patient¿s status was "good".The customer did not respond to further questions upon request; therefore, it is unknown whether "balloon wasn't inflated" involved a device malfunction, user error, or other.This report is being raised due to the reported injury of a perforated uterus.

• 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: 23254172
• Report Number: 1320894-2025-00237
• Device Sequence Number: 10419191
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)270303(10)202503031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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 Catalogue Number: 60-6085-200A
• Device Lot Number: 202503031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic