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

Model Number 60-6085-201A

Device Problems Detachment of Device or Device Component (2907); Fail-Safe Problem (2936); Unintended Deflation (4061)

Patient Problem Uterine Perforation (2121)

Event Date 05/12/2022

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a, medium, was used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported that the ¿vcare was defective.During the case, the lock failed.The tip balloon not only deflated, but the entire balloon came off the tip of the manipulator.With the tip balloon coming off the manipulator shaft, the vcare perforated the uterus.With the lock failing, the cup was not static and made the colpotomy almost impossible.The cup also broke during the end of the case.The vcare failed at three different parts of the device.The tip balloon had to be found at the end of the case in which it was recovered inside the vagina.¿ the procedure was completed, no alternate device was used, there was no delay to the surgery, and there was no patient injury.Further assessment found, all of the device components were located, and no components were left in the patient or surgical site.No medical/surgical intervention or extended hospitalization was required for patient.Patient is said to be doing "good/recovering".This report is being raised on the basis of injury due to perforation of the uterus.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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.

Manufacturer Narrative

The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised that to unlock the locking mechanism by turning the thumbscrew counter-clockwise (anti-clockwise) and retract to the handle.3.A.Swipe 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.(figure #4) 4.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.

Event Description

The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a ¿ medium, was used during a total laparoscopic hysterectomy on 12may22 when it was reported that the ¿vcare was defective.During the case, the lock failed.The tip balloon not only deflated, but the entire balloon came off the tip of the manipulator.With the tip balloon coming off the manipulator shaft, the vcare perforated the uterus.With the lock failing, the cup was not static and made the colpotomy almost impossible.The cup also broke during the end of the case.The vcare failed at three different parts of the device.The tip balloon had to be found at the end of the case in which it was recovered inside the vagina.¿ the procedure was completed, no alternate device was used, there was no delay to the surgery, and there was no patient injury.Further assessment found, all of the device components were located, and no components were left in the patient or surgical site.No medical/surgical intervention or extended hospitalization was required for patient.Patient is said to be doing "good/recovering".This report is being raised on the basis of injury due to perforation of the uterus.

• Brand Name: VCARE 200A - MEDIUM
• 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14461411
• MDR Text Key: 293366727
• Report Number: 1320894-2022-00098
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)231129(10)202111291
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202111291
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic