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

Catalog Number	60-6085-200A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
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 (mw5153636) received on 23apr24.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 60-6085-200a vcare 200a - small.The report states that on 25mar24 ¿the balloon from the vcare uterine manipulator fell off inside patient abdomen.The balloon fell of the manipulator and into abdomen.It was retrieved by surgeon and accounted for.¿.There was no report of injury or impact to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review shows a total of one (1) device for this lot number and failure mode.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 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 counter-clockwise (anti-clockwise) and retract to the handle.Swipe a 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 that 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
This complaint was created due to the receipt of a medwatch report (mw5153636) received on 23apr24.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 60-6085-200a vcare 200a - small.The report states that on (b)(6) 2024,"the balloon from the vcare uterine manipulator fell off inside patient abdomen.The balloon fell of the manipulator and into abdomen.It was retrieved by surgeon and accounted for".There was no report of injury or impact to the patient or user.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: 19297036
• Report Number: 1320894-2024-00128
• Device Sequence Number: 6981010
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)251008(10)202310091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 10/08/2025
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202310091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic