MAUDE Adverse Event Report: CONMED CORPORATION VCARE, LARGE (37MM) CUP; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 60-6085-202A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device in question has been received by conmed and has entered into the evaluation process.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a v-care, large (37mm) cup, 60-6085-202a, lot 202003021, that was received by conmed sample lab in utica on 23rd july2020.The device in question had been returned with a label associated with return goods authorization rga# 20-59502 issued to (b)(6) hospital (b)(6) campus.The note attached simply stated "came apart in use".A search of the complaint system did not find a record previously reported by the user facility with this same incident or product details.There is no contact information listed for the facility and no other information made available at this time.Although there is limited information on this reported issue, due to previous filings for similar worded events with this device, this incident will be reported on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

D:10 correction of date the product was received at conmed.The reported complaint of device breakage is confirmed.Conmed received one 60-6085-202a in opened original packaging.The reported lot number was verified.A visual inspection of the returned device was performed.There are no signs of adhesive inside of the uterine balloon or on the shaft of the device.All pieces of the device were returned, however the complaint device was received disassembled.Measurements were taken, the inner diameter of the green cervical cup measured at.208 inches which is within spec.The blue cone measured at.200 inches which is out of spec on the high end.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 65 complaints, regarding 70 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.(b)(4).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, LARGE (37MM) CUP
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica, ny
• MDR Report Key: 10338747
• MDR Text Key: 201054449
• Report Number: 1320894-2020-00334
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/02/2022
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202003021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 08/05/2020
• Patient Sequence Number: 1