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

Catalog Number	60-6085-202A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6085-202a, lg,uterine manipulator device was being used during a total laparoscopic hysterectomy procedure on (b)(6) 2025 when it was reported ¿i was contacted by hospital staff to report the disassembly of the vcare during the procedure.It was confirmed that all parts were retrieved.There was limited time delay and normal operative procedure was followed to complete case.¿ the procedure was completed with the use of the same alternate device and a 5-minute delay.There was no report pf injury, medical or surgical 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
Reported event of the device coming apart is confirmed.Examination of the returned used device 60-6085-202a found the balloon and the green cup fell off the device.Further visual examination could not find a specific reason as to why the balloon would fall off, but because it did, the green cup fell off as well.See attached photos of the returned used device.Root cause cannot be identified however based upon the evaluation and photographs, a possible cause for this issue is the use of excessive force during removal of the device from the patient.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 23 complaints, regarding 23 devices, for this device family and failure mode.During this same time frame 683,345 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 0.00003.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 counterclockwise (anticlockwise) 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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6085-202a, lg,uterine manipulator device was being used during a total laparoscopic hysterectomy procedure on (b)(6) 2025 when it was reported ¿i was contacted by hospital staff to report the disassembly of the vcare during the procedure.It was confirmed that all parts were retrieved.There was limited time delay and normal operative procedure was followed to complete case.¿ the procedure was completed with the use of the same alternate device and a 5-minute delay.There was no report pf injury, medical or surgical 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.

• 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: 22529337
• Report Number: 1320894-2025-00175
• Device Sequence Number: 7473736
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)270331(10)202503311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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 Catalogue Number: 60-6085-202A
• Device Lot Number: 202503311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic