MAUDE Adverse Event Report: CONMED UTICA VCARE DX; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number	60-6080-000A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device, 60-6080-000a, vcare dx, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿uterine perforation occurred during device insertion caused by too much manipulator rigidity and low uterine mobility.Not very versatile device.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions have been sent to the reporter for follow up; however, to date we have not received a response.This report is being raised due to the reported injury of uterine perforation during the procedure.
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.
Additional Manufacturer Narrative
The device will not be returned for evaluation 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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: improper use of this or any intrauterine instrument can result in perforation of the uterine wall and subsequent bleeding.Never use this device with the intrauterine balloon deflated.Vcare® dx¿ must be inserted into the uterus along the direction of the uterine cavity, i.E.Anteriorly in anteverted uteri, posteriorly in retroverted uteri, to reduce potential for uterine perforation.Perform pelvic examination to determine the direction of the uterus and then sound the cavity to assess the uterine depth.Extra caution should be exercised in the case of a very small uterus.Do not use vcare® dx¿ if the uterus sounds to less than 4.0cm.Vcare® dx¿ is not recommended for use in a large, post-partum uterus.Physicians must exercise sound judgment and care, should they choose to use this device.Movements of the manipulator within the uterus may cause lacerations within the uterine wall and bleeding.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, 60-6080-000a, vcare dx, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿uterine perforation occurred during device insertion caused by too much manipulator rigidity and low uterine mobility.Not very versatile device.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions have been sent to the reporter for follow up; however, to date we have not received a response.This report is being raised due to the reported injury of uterine perforation during the procedure.Updated information received 26jul23: the customer reported that the device, 60-6080-000a, vcare dx, was being used during a vl adnexectomy-ovarian cyst vl procedure on (b)(6) 2023.The client claims that the end of the manipulator is too stiff, and this feature can cause damage to the uterus (perforation).The client would like to have a soft end of the uterus.Uterine perforation occurred during device insertion caused by too much manipulator rigidity and low uterine mobility.Suturing of the right lateral fundus was required.No further medical intervention or hospitalization was reported.The procedure was completed with a 5-minute delay.Conmed's awareness date was updated to be 17jul23.The patient is doing well and has not had any problems due to the short extension of the surgery.

• Brand Name: VCARE DX
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17371112
• Report Number: 1320894-2023-00143
• Device Sequence Number: 14409707
• Product Code: LKF
• UDI-Device Identifier: 10653405003717
• UDI-Public: (01)10653405003717(17)231004(10)202110041
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 10/04/2023
• Device Catalogue Number: 60-6080-000A
• Device Lot Number: 202110041
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic