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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 27 reports, regarding 32 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 0.00005.Per the instructions for use, the user is advised the following: re-attach the syringe to the luer connector at the end of the pilot balloon; fully aspirate the air from the intrauterine balloon to deflate.This will allow the intrauterine balloon to be removed from the uterus.There are 5 parts/components to the vcare cervical elevator retractor.These are: the balloon; the forward ¿cervical¿ cup; the back or vaginal cup; the locking assembly with thumb screw; 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 customer reported that the device, 60-6085-201a, vcare 200a ¿ medium was being used on (b)(6) 2022 during a robot-assisted laparoscopic vaginal hysterectomy bs/si to open tahbso w/ cystoscopy and stent placement and ¿when it was determined to convert from robotics to an open procedure the uterine manipulator was removed.The handle and shaft were removed however the balloon and cuff stayed in the vaginal vault and had to be manually retrieved.¿.There was no injury to the patient or user reported.There was also no report of medical intervention or hospitalization for this event.The procedure was completed without an alternate device.Further assessment found that 10ml of air was fully aspirated from the intrauterine balloon prior to removal.The screw locking mechanism was twisted and unlocked under the supervision of the surgeon.Finger was inserted and swept along entire circumference of the vcare cup prior to removal to release the suction between the blue vaginal cup and the vaginal canal wall.The vaginal (blue) cup was retracted once the screw was loosened.No substantial force was needed to remove the vcare device.There was little to no delay.Patient was discharged home on (b)(6) 2022.No interventions required due to faulty instrumentation.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 13994699
• MDR Text Key: 290053559
• Report Number: 1320894-2022-00072
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)220908(10)202009081
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202009081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic