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

Model Number 60-6085-201A

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device is being 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 that the device, 60-6085-201a, vcare 200a - medium, was being used during a laparoscopic total hysterectomy procedure on (b)(6)2022 when it was initially reported, ¿one hour after the start of use, the cervical cup and vaginal cup passed through the intrauterine balloon and disassembled in the patient's body.In addition, even if the surgeon tried to remove the air from the uterus balloon, it could not be removed.¿.On (b)(6)2022 the reported statement was updated to, ¿one hour after the start of use, i tried to pull the uterus out of the body, but it did not move and the air in the balloon could not be released.When i pulled it forcibly, the uterus remained inside the body, and all the parts, including the dislodged balloon, cervical cup, and vaginal cup, came out from the body.¿.The procedure was reported as having been completed without any injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The customer reported that the device, 60-6085-201a, vcare 200a - medium, was being used during a laparoscopic total hysterectomy procedure on (b)(6) 2022 when it was initially reported, ¿one hour after the start of use, the cervical cup and vaginal cup passed through the intrauterine balloon and disassembled in the patient's body.In addition, even if the surgeon tried to remove the air from the uterus balloon, it could not be removed.¿.On 30nov22 the reported statement was updated to, ¿one hour after the start of use, i tried to pull the uterus out of the body, but it did not move and the air in the balloon could not be released.When i pulled it forcibly, the uterus remained inside the body, and all the parts, including the dislodged balloon, cervical cup, and vaginal cup, came out from the body.¿.The procedure was reported as having been completed without any injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one 60-6085-201a in original opened package.Lot number was verified.Performed a visual inspection, the device came completely disassembled.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.(b)(4).Per the instructions for use, the user is advised, 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.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15994792
• MDR Text Key: 307169129
• Report Number: 1320894-2022-00243
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)240131(10)202201311
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202201311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic