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

Model Number 60-6085-200A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Tears (2516)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Please note this report is being resubmitted following an unsuccessful submission attempt on 19july2021 due to a system error.Reported event is confirmed.One 60-6085-200a returned opened in unoriginal packaging.The lot number of the device could not be verified.A visual inspection found the green cervical cup and blue uterine balloon had detached from the v-care tube.The white shrink sleeve cuff was removed from the v-care along with the uterine balloon.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 five (5) complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 99 complaints, regarding 141 devices, for this device family and failure mode.During this same time frame 453,552 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 0.0003.Per the instructions for use, the user is advised the following: 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 counter-clockwise (anti-clockwise) and retract to the handle.A.Swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage b.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, 60-6085-200a, was being used on (b)(6) 2021 during a robotic hysterectomy procedure and ¿upon removal of the small v-care from the vagina, it was noted that both the balloon and the green cup came off.The vcare withdrew from the vagina with ease, no dragging or obstruction noted.There was a degloving of the innermost portion of the vagina (near the vaginal cuff) noted.It is thought that this degloving occurred due to the defective v-care.¿ upon further assessment it was found, that all pieces of the device were retrieved and the proximal portion of the vagina was degloved.The procedure was completed and there was a delay to assess extent of injury; the duration was not reported.There was no report of extended hospitalization, or medical intervention for the patient.This report is being raised on the basis of injury due to the degloving of the proximal vagina.

• Brand Name: VCARE 200A - SMALL
• Type of Device: 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: 12413656
• MDR Text Key: 269533636
• Report Number: 1320894-2021-00356
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)211201(10)201912021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 201912021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other