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

Model Number	60-6085-201
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Uterine manipulator fell apart while being used inside patient's vaginal cavity during a robotic hysterectomy.

• Brand Name: VCARE MEDIUM
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 23592383
• Report Number: 23592383
• Device Sequence Number: 18613403
• Product Code: LKF
• UDI-Device Identifier: 30653405061803
• UDI-Public: (01)30653405061803
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2025
• Report Date (Section F): 09/25/2025

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 Model Number: 60-6085-201
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 202503101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 09/25/2025