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

Catalog Number 60-6085-201A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

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

The complaint was created due to a sus voluntary event report # mw5100934 received by conmed 11may2021.The customer reported an issue with the vcare that occurred during use on (b)(6) 2021.A search of the complaint system did not find a complaint matching the description of reported incident.It is noted on the document that "unit came apart in 3 section when in use inside patient." the event report type is noted as a "malfunction", the event outcome is blank but adverse event is marked "n".No initial reporter, contact or facility information was provided.When additional information was requested from the fda, it was indicated the reporter requested to be anonymous and no other information was made available.No information was provided as to the specific lot number or size vcare used.Vcare medium, item 60-6085-201a, has been chosen as default for purpose of this fda reporting.As there is no indication of patient injury or impact, this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

H10: investigation of the customer's complaint of the vcare device coming apart is inconclusive.The device in question, used in the procedure, is not available for evaluation by conmed.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, and root cause can not be identified.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.A two-year review of complaint history revealed there has been a total of 85 complaints, regarding 110 devices, for this device family and failure mode.During this same time frame 457,448 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 0.0002.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 & replace it with a new vcare.The cervical/vaginal cup locking mechanism must be locked at all times when using vcare for uterine manipulation.If lock inadvertently becomes open, secure it immediately before proceeding.The ifu gives direction for removing the vcare after use including: 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.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.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.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: 11881919
• MDR Text Key: 252930813
• Report Number: 1320894-2021-00256
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/30/2021
• Patient Sequence Number: 1