MAUDE Adverse Event Report: CONMED VCARE; Cannula, Manipulator/Injector, Uterine

Catalog Number	60-6085-201A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of a customer that the devic, 60-6085-201a, medium, uterine manipulator, was used in a robotic assisted total laparoscopic hysterectomy, bilateral salpingectomy, cystoscopy procedure on (b)(6) 2026, and experienced ¿screw failures on the device." further assessment found "assisted on a robotic hysterectomy and the vcare uterine manipulator ¿malfunctioned¿ - the part of the manipulator that locks down the cup has failed in at least 2 cases and was told by the or techs there have been similar issues with the device in other surgeries.The white screw loosens and the manipulator advanced and led to uterine perforation and can only be ratcheted down tightly with an instrument." there was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury of uterine perforation.
Additional Manufacturer Narrative
G3 initial awareness date was (b)(6) 2026.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: beth madeline ; 525 french rd; utica, NY 13502 ; +1(727)470-8358
• MDR Report Key: 50068392
• Report Number: 1320894-2026-00186
• Device Sequence Number: 16004039
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)280301(10)202603021
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 202603021
• 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: 08/12/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown