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

Catalog Number 60-6085-201A

Device Problem Unintended Movement (3026)

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

Event Date 03/17/2022

Event Type  malfunction  

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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the device, 60-6085-201a, vcare 200a medium was being used on (b)(6) 2022 during an unknown procedure and the "handle was loose (wasn¿t staying in one place, kept twisting when they inserted vcare into patient)." the procedure was completed.Further assessment has been sent; however, to date no information has been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the device, 60-6085-201a, vcare 200a ¿ medium was being used on (b)(6) 2022 during an unknown procedure and the ¿ handle was loose (wasn¿t staying in one place, kept twisting when they inserted vcare into patient)¿.The procedure was completed.Further assessment has been sent; however, to date no information has been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is confirmed.Received two 60-6085-201a in opened original packaging.Lot number was not verified.Performed a visual inspection, one device did not have any signs of abnormalities or defects.The shaft on the second device is broken within the handpiece.Performed a functional inspection, the first device functioned as intended and the handle stayed in place.The handle on the second device rotates 360 degrees.A two-year lot history review could not be performed since a lot number was not provided.A review of the device history record could not be performed since a lot number was not provided.A two-year review of complaint history revealed there has been a total of 82 reports, regarding 107 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: 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.A.Swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage b.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.This issue will continue to be monitored through the complaint system to assure patient safety.

• 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: 14072683
• MDR Text Key: 288981920
• Report Number: 1320894-2022-00074
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic