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

Catalog Number 60-6085-201A

Device Problem Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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 for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a - medium, was being used during hysterectomy procedure on an unknown date when it was reported, ¿¿they tried switching to a medium manipulator and the balloon would not deflate.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with a 1-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The device history review could not be conducted because the lot number is not known.The lot history review could not be conducted because the lot number is not known.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 18 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: remove the vcare from its sterile packaging and inspect for damage caused by shipping.Discard if any damage is noted.Draw 7-10 cc of air into a standard syringe and insert it into the luer connection at the end of the pilot balloon.Test the intrauterine balloon by injecting air with the syringe and checking to see if balloon remains inflated.If balloon does not remain inflated, do not use.Discard and select another vcare unit.After the successful balloon test, deflate the balloon by removing all air with the syringe.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a - medium, was being used during hysterectomy procedure on an unknown date when it was reported, ¿¿they tried switching to a medium manipulator and the balloon would not deflate.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with a 1-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE 200A - MEDIUM
• Type of Device: 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18370978
• MDR Text Key: 331058218
• Report Number: 1320894-2023-00270
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic