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

Catalog Number	60-6085-202A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 60-6085-202a, vcare 200a - large, was being used during an unknown procedure on (b)(6) 2023 when it was reported "product snapped in half while in use.¿ the procedure was completed with the use of the same alternate device.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported injury due to the possibility of foreign body left inside the patient.
Additional 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.H3 other text : device not yet received.
Additional Manufacturer Narrative
The device has not been returned to date 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.(b)(4).Per the instructions for use, the user is advised 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 counterclockwise (anti-clockwise) and retract to the handle.Swipe finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.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.Upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 60-6085-202a, vcare 200a - large, was being used during an unknown procedure on (b)(6) 2023 when it was reported "product snapped in half while in use.¿.The procedure was completed with the use of the same alternate device.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported injury due to the possibility of foreign body left inside the patient.
Additional Manufacturer Narrative
Update: received one 60-6085-202a in opened original packaging.Lot number was verified.Performed a visual inspection, the shaft of the device is snapped in half.All pieces of the device were returned.B1 updated from adverse event to product problem.H1 updated from injury to malfunction.B5 updated from injury to malfunction statement.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.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised 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 counterclockwise (anti-clockwise) and retract to the handle.Swipe finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 60-6085-202a, vcare 200a - large, was being used during an unknown procedure on (b)(6) 2023 when it was reported "product snapped in half while in use." the procedure was completed with the use of the same alternate device.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE 200A - LARGE
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17739152
• Report Number: 1320894-2023-00181
• Device Sequence Number: 12135805
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)230913(10)202109131
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202109131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 02/08/2024
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/24/2023; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic