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 Date 01/29/2024

Event Type  malfunction  

Event Description

The customer reported that 60-6085-201a, vcare 200a - medium, was being used during a single port total laparoscopic hysterectomy procedure on (b)(6) 2024 when it was reported ¿item would not deflate.¿.The procedure was completed using the same alternate device.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

Received one 60-6085-201a in opened original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection.The device functioned as intended.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.(b)(4).Per the instructions for use, the user is advised to 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 customer reported that 60-6085-201a, vcare 200a - medium, was being used during a single port total laparoscopic hysterectomy procedure on (b)(6) 2024 when it was reported "item would not deflate." the procedure was completed using the same alternate device.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18941695
• MDR Text Key: 338139685
• Report Number: 1320894-2024-00073
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)250813(10)202308141
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 202308141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic