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	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5144558 on 08sep23.The report was found to be written against 60-6085-202a, vcare 200a - large, that was being used during a tah bso laparoscopic, cystoscopy procedure on (b)(6) 2023.The report stated, ¿resident had v-care in vaginal to manipulate the uterus during surgery.When she lifted the uterus for better visualization, the instrument snapped.¿.No further information was indicated by the provider for additional information.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.The current status of the patient was reported as ¿discharged to home stable¿.This report is being raised on reported injury due to the possibility of the patient retaining a foreign body.
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5144558 on 08sep23.The report was found to be written against 60-6085-202a, vcare 200a - large, that was being used during a tah bso laparoscopic, cystoscopy procedure on 20jul23.The report stated, ¿resident had v-care in vaginal to manipulate the uterus during surgery.When she lifted the uterus for better visualization, the instrument snapped.¿.No further information was indicated by the provider for additional information.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.The current status of the patient was reported as ¿discharged to home stable¿.This report is being raised on reported injury due to the possibility of the patient retaining a foreign body.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was 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.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.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.There are 5 parts/components to the vcare cervical elevator retractor.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: 17817623
• Report Number: 1320894-2023-00192
• Device Sequence Number: 2440206
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic