MAUDE Adverse Event Report: CONMED UTICA VCARE 200A - SMALL; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	60-6085-200A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event of ¿proximal occluder portion had snapped off or at least was no longer attached to the shaft of the vcare¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 46 reports, regarding 50 devices, for this device family and failure mode.During this same time frame 527,152 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 0.00009.Per the instructions for use, the user is advised the following: 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 counter-clockwise (anti-clockwise) and retract to the handle.Swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Fully retract the vaginal cup to the handle.Carefully remove the device from the vagina.Do not use excessive force to avoid traumatizing the vaginal canal.Upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6085-200a, vcare 200a - small was being used on (b)(6) 2023 during a total laparoscopic hysterectomy procedure and ¿the vcare that was being used, the proximal occluder portion had snapped off or at least was not longer attached to the shaft of the vcare when the uterus was removed.There were no issues with the removal of the uterus from the patient but that portion was no longer attached.¿.There was no injury or impact to the patient or user.The procedure was completed with no delay and no alternate device was used.After further assessment it was found ¿we could not tell if the blue vaginal cup simply fell off or slid off the end.Everything was very easily retrieved from the surgical site, no issues there.¿ there was no substantial force used when removing the vcare.It was noted, "the uterus was quite small.There was no complaint from the staff while using the device, it had been a very tough case from the surgeons standpoint." this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE 200A - SMALL
• 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16762337
• Report Number: 1320894-2023-00072
• Device Sequence Number: 12307485
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)240410(10)202204111
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 Expiration Date: 04/10/2024
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202204111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic