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

Catalog Number 60-6085-201A

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  Injury  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (5105957) received on 19jan22.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 60-6085-201a, vcare 200a - medium.The report states that on (b)(6) 2021 the vcare balloon was inflated and would not deflate.There was required intervention and an injury.No other information is known and the reporter chose to remain anonymous so further assessment questions could not be sent.It is not known how the patient was injured or what intervention was required.This report is being raised on the basis of injury due to unknown injury and unknown required intervention reported on a medwatch.

Manufacturer Narrative

Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 (b)(4), 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 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.Test the intrauterine balloon for proper inflation and function before insertion; do not insert vcare with intrauterine balloon inflated.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (b)(4) received on (b)(6) 2022.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 60-6085-201a, vcare 200a - medium.The report states that on (b)(6) 2021 the vcare balloon was inflated and would not deflate.There was required intervention and an injury.No other information is known and the reporter chose to remain anonymous so further assessment questions could not be sent.It is not known how the patient was injured or what intervention was required.This report is being raised on the basis of injury due to unknown injury and unknown required intervention reported on a medwatch.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13506672
• MDR Text Key: 289501614
• Report Number: 1320894-2022-00031
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202108231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic