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

Model Number	60-6085-200A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-6085-200a, vcare 200a ¿ small was being used on (b)(6)23 during an unknown procedure and ¿the handle part turns round and round.¿ the procedure was completed with an alternate unknown device.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.Conmed japan has reported this event and a medwatch report will be filed in conjunction with all ous adverse events.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
Additional Manufacturer Narrative
Received one 60-6085-200a in opened original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were found.Performed a functional inspection, the complaint was confirmed.The handle on the device spins since it was loose.Root cause cannot be determined, however, based upon evaluation of the device and ifu; a possible cause of this event could be excessive force.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 96 reports, regarding 112 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: 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 counterclockwise (anti-clockwise) and retract to the handle.Swipe finger around the edge of the vaginal cup to separate tissue from the cup to prevent tissue damage.Fully retract the vaginal cup to the handle.Carefully remove the device form the vagina.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-6085-200a, vcare 200a ¿ small was being used on (b)(6) 2023 during an unknown procedure and ¿the handle part turns round and round.¿ the procedure was completed with an alternate unknown device.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.Conmed japan has reported this event and a medwatch report will be filed in conjunction with all ous adverse events.This report is being raised due to the reported 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: 17072955
• Report Number: 1320894-2023-00109
• Device Sequence Number: 6105218
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)240327(10)202203281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 03/27/2024
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202203281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic