MAUDE Adverse Event Report: CONMED VCARE; cannula, manipulator/injector, uterine

Catalog Number	60-6085-200A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G3 initial awareness date: 06aug2026 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
A sales representative reported on behalf of a customer that the device, 60-6085-200a, small,uterine manipulator,vaginal, was used in an unnamed procedure on(b)(6) 2026, and ¿the screw came loose.Instead of opening a new item the nurse held the unit in place for the remainder of the surgery.There was no delay our patient injury.¿.The procedure was completed.There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: beth madeline ; 525 french rd; utica, NY 13502 ; +1(727)470-8358
• MDR Report Key: 50260235
• Report Number: 1320894-2026-00198
• Device Sequence Number: 10701343
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)280322(10)202603231
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 60-6085-200A
• Device Lot Number: 202603231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown