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

Catalog Number 60-6085-202A

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Uterine Perforation (2121)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

The device in question, used in the procedure, is not available for evaluation by conmed.The facility is expected to return a stock sample of the same lot number.At time of filing, although expected, the stock sample device has not been returned to conmed for evaluation.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

The customer reported issues with vcare large(37mm) cup, 60-6085-202a, lot 202102011 experienced by methodist le bonheur healthcare on (b)(6) 2021.They reported that during a robotic hysterectomy, they tested the vcare before patient use and it inflated.When they used it on the patient it deflated and punctured the patient's uterus.It is indicated the procedure was successfully completed with no further impact/harm to the patient as the uterus was being removed with the hysterectomy.Additional information was received that indicated the bulb was manually checked prior to insertion, the vcare was inserted, green cervical cup was secured, sutured and in place about 10 minutes before the issue occurred.It was noted the balloon was deflated but remained on the shaft.Further clarification of the incident was received that indicated all 3 balloons in question had been filled with air less than or equal to 10cc.The physician had inserted a vcare, the balloon did not hold inflation, so it was removed and another inserted.The same issue occurred with the second vcare, it also was removed.A third vcare was inserted, inflated, and secured as the balloon was keeping the inflation at that time.After approximately 10 minutes, the physician started the procedure and began manipulating the uterus.There was no visualization within the uterus and as such the physician was unable to visualize the balloon, however at this time, it was known by the physician that the vcare balloon had deflated but the vcare was not removed from the patient.The physician chose to continue the procedure using the same vcare without a balloon.Once the physician started to manipulate the uterus using the vcare, the vcare was seen to come through the uterus wall.The procedure was completed robotically using the same vcare with no other reported issues.It was confirmed the patient was discharged as usual and is fine.This report is being raised on the basis of injury for the uterus being punctured.

Manufacturer Narrative

Investigation of the customer's reported issue and complaint was confirmed based on evaluation of the returned device and information provided by the reporter.Conmed received received five 60-6085-202a.Two were returned opened in original packaging.Three were returned unopened in original packaging.The lot number of the devices - 202103011 was verified.A visual inspection was performed with no obvious defects or abnormalities found.A functional test was performed on all five devices.The devices were individually tested for leaks by submerging the device in 1000ml's of water and injecting 10cc's of air into the pilot balloon.Both devices returned opened in original packaging (used in the procedure) displayed proximal leaks in the pilot balloon.The three unopened v-care devices (from the facility stock) did not display any leaks during functional test.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is advised to remove the vcare from its sterile packaging and inspect for damage caused by shipping.Discard if any damage is noted.Draw 7-10 cc of air into a standard syringe and insert it into the luer connection at the end of the pilot balloon.Test the intrauterine balloon by injecting air with the syringe and checking to see if balloon remains inflated.If balloon does not remain inflated, do not use.Discard and select another vcare unit.After the successful balloon test, deflate the balloon by removing all air with the syringe.The ifu also 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.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 13502 5994
• MDR Report Key: 11776505
• MDR Text Key: 249034236
• Report Number: 1320894-2021-00194
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202103011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 05/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other