MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM (34MM) CUP; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 60-6085-201A

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported issues with a vcare medium (34mm) cup # 60-6085-201a, lot 201912161 that bellin hospital, green bay, wi experienced on 24sept2020.Information received was that the vcare cup broke into pieces during a hysterectomy on (b)(6) 2020.It is noted the procedure was completed however, no alternate was used.Additional information received indicates there was no impact/injury to the patient.The cup mentioned refers to the green cervical cup, and it was clarified that pieces of the cup broke off while in use but were removed.The procedure was completed after all pieces were removed with no further issues.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the fragments that fell into the patient were removed.

Manufacturer Narrative

The reported device has not been returned to conmed for evaluation and its location is unknown.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, and root cause can not be identified.Should the device be returned an evaluation will be performed and upon completion of the complaint investigation a supplemental and final report will be filed.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 were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history for similar failure modes revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 473,992 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 0.000006.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user to check the pilot balloon frequently to ensure inflation of the intrauterine balloon.If the intrauterine balloon ruptures, the pilot balloon will not feel firm when squeezed between your fingers.If the intrauterine balloon has ruptured, stop all manipulation immediately, remove the vcare and replace it with a new vcare unit.The ifu also gives direction as to removing the vcare after use, including but not limited to :reattach the syringe to the luer connector at the end of the pilot balloon and 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 screw counter-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.These are: 1) the balloon; 2) the forward "cervical" cup; 3) the back or vaginal cup; 4) the locking assembly with thumb screw; 5) the metal shaft and handle with balloon inflation valve.For safe removal of the vcare device from the patient, follow instructions.Failure to separate the vaginal cup from the tissue may result in detachment of cervical cup and/ or patient injury.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: VCARE MEDIUM (34MM) CUP
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 10622006
• MDR Text Key: 209853010
• Report Number: 1320894-2020-00426
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2021
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201912161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Patient Sequence Number: 1