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

Catalog Number	60-6085-201A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6085-201a, medium,uterine manipulator was being used on 22may26 and ¿¿tip is slipping.Slipping tip is resulting in perforated uterus.¿ per further assessment it was reported that "the white tab on the side of the vcare shaft doesn't lock down.That the vcare moves (doesn't stay locked on the blue occluder), so the shaft of vcare goes further than they want into the patient and this is causing the perforated uterus.This was during a robotic hysterectomy, yes, the surgery was completed, no delays.Patient was fine, they were able to complete the procedure." this report is being raised due to the reported injury of perforated uterus.
Additional Manufacturer Narrative
G3 initial awareness date was 22may26.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.

• Brand Name: VCARE
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 25475129
• Report Number: 1320894-2026-00148
• Device Sequence Number: 9933260
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)280105(10)202601051
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202601051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown