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

Model Number 60-6085-200A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of the reported event is inconclusive.The device has not been returned for evaluation.No photographic evidence was provided.Therefore, the reported failure cannot be verified, & root cause cannot be identified.The device history record manufacturing documents have been reviewed & found no abnormalities that would contribute to this issue.A two-year lot history review was conducted & found this is the only complaint this lot number & failure mode.A two-year review of complaint history for similar failure modes revealed there has been a total of 93 complaints, regarding 127 devices, for this device family & failure mode.During this same time frame (b)(4)devices have been manufactured & shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).The instructions for use (ifu) provides the user with information regarding proper care & use of this device.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.The ifu also gives specific direction as to carefully removing the vcare after use; do not use excessive force to avoid traumatizing the vaginal canal.Upon removing vcare, the surgeon should visually inspect the vcare device & patient to make sure the entire vcare device was properly removed & no components were retained in the patient.For safe removal of the vcare device from the patient, follow instructions.The cervical/vaginal cup locking mechanism must be locked at all times when using vcare for uterine manipulation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed recently received notification via fda sus voluntary event report # mw5101751 of a device issue.The sus report indicates issues with a v vcare small (32mm) cup, lot 202101121 that bjc recently experienced on (b)(6) 2021.The information received indicates while trying to remove the uterus, the distal portion of the vcare, including the green cup and blue balloon, became disconnected from the handle and remained inside the patient while the handle was pulled away from the vagina.The uterus was still inside the patient as well as the disconnected parts.(green cervical cup and balloon tip) physicians quickly worked to remove the remaining objects from the patient.They were able to assess an intact vcare and disassemble it off the field and confirmed all parts were successfully removed from the patient.To date, although multiple attempts have been made to gather additional information, no response has been received and no clarification has been made available.This incident will be reported on the basis of malfunction with potential for injury upon reoccurrence due to the device coming apart.

• Brand Name: VCARE 200A - SMALL
• 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: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12388236
• MDR Text Key: 270650863
• Report Number: 1320894-2021-00321
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)230112(10)202101121
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/12/2023
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202101121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1