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

Model Number 60-6085-201A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

Reported event is confirmed.Customer event ¿vcare device that broke inside of a patient¿ was confirmed based on photographic evidence.The device will not be returned for evaluation, but photographic evidence has been provided that confirmed the reported issue.A two-year lot history review was conducted and found a total of 2 similar events involving 2 devices for this lot number.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 review of complaint history revealed there has been a total of 73 reports, regarding 79 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: prior to device removal, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.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 device, 60-6085-201a, vcare 200a ¿ medium was being used on (b)(6) 2022 during a robotic hysterectomy procedure and ¿vacre device that broke inside of a patient today¿ it is not known if the patient was injured.It is not known if all of the device was recovered from the patient.Further assessment was sent; however, to date the facility has not provided any more information.This report is being raised on the basis of potential injury based upon the lack of information regarding recovery of fragments from the patient and patient injury.

Event Description

Update: device evaluation shows that all pieces of the device were recovered from the patient.The sales representative reported on behalf of the customer that the device, 60-6085-201a, vcare 200a ¿ medium was being used on 14feb2022 during a robotic hysterectomy procedure and ¿vcare device that broke inside of a patient today¿ it is not known if the patient was injured.It is not known if all of the device was recovered from the patient.Further assessment was sent; however, to date the facility has not provided any more information.This report is being raised on the basis of potential injury based upon the lack of information regarding recovery of fragments from the patient and patient injury.

Manufacturer Narrative

Updates: the following fields were updated to reflect new information that was obtained when the device was returned to conmed for evaluation.B1, b2, b5, d9, h3, and type of investigation.Manufacturer narrative: reported event is confirmed.Received one 60-6085-201a in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the device was returned disassembled.Performed a functional inspection using pin gages (c3244), the inner diameter of the blue vaginal cone measured out of spec on the high end measuring at.203".The inner diameter of the green cervical cup measured in spec at.207" per drawing number 7174 and 17760.All pieces were returned.A two-year lot history review was conducted and found a total of (b)(4) similar events involving (b)(4) devices for this lot number.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 review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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 the following: prior to device removal, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Update: it was previously reported that conmed "performed a functional inspection using pin gages (c3244), the inner diameter of the blue vaginal cone measured out of spec on the high end measuring at.203".The inner diameter of the green cervical cup measured in spec at.207" per drawing number 7174 and 17760." in addition, there is a possibility that the inner diameter of the blue cup may have stretched over a period of time and during use.This issue is not indicative of a manufacturing defect.Manufacturer narrative: a two-year lot history review was conducted and found a total of (b)(4) similar events involving (b)(4) devices for this lot number.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 review of complaint history revealed there has been a total of (b)(4), regarding (b)(4), 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 the following: prior to device removal, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Update: device evaluation shows that all pieces of the device were returned.The sales representative reported on behalf of the customer that the device, 60-6085-201a, vcare 200a ¿ medium was being used on (b)(6) 2022 during a robotic hysterectomy procedure and ¿vcare device that broke inside of a patient today¿ it is not known if the patient was injured.It is not known if all of the device was recovered from the patient.Further assessment was sent; however, to date the facility has not provided any more information.This report is being raised on the basis of potential injury based upon the lack of information regarding recovery of fragments from the patient and patient injury.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13720974
• MDR Text Key: 286938613
• Report Number: 1320894-2022-00056
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

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?: Yes
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 04/07/2022; 04/07/2022
• Supplement Dates FDA Received: 04/15/2022; 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic