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

Catalog Number 60-6085-201A

Device Problem Break (1069)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

On behalf of the customer in (b)(6), the distributor reported issues with the vcare medium (34mm) cup, # 60-6085-201a, lot 202011021, that were experienced on (b)(6) 2021.Information received indicates ¿doctor reports that the manipulator broke in surgical procedure¿.It is noted the tip/piece did not fall off into the patient or surgical site.It is also noted there was no impact or injury to the patient.No other information was provided.As per the distributor, no clarification can be requested as the original reporter to the distributor has requested confidentiality.This report is being raised on the basis of previous fda filings for similar malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.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

H10: investigation of reported issue is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure cannot be verified, & root cause cannot be identified.Review of the dhr found no abnormalities that would contribute to this reported event.Two-year lot history review shows this is the only complaint for this reported lot number & failure mode.Two-year review of complaint history for similar failure modes revealed a total of 164 complaints, regarding 213 devices, for device family & failure mode.During this same time frame 481,456 devices were manufactured & shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0004.Instructions for use (ifu) provide the user with detailed information regarding proper care & use of device.Ifu also gives specific direction as to safely & carefully removing the vcare after use.Ifu advises unlock locking mechanism & retract to the handle.Swipe finger around edge of vaginal cup & separate the tissue from the cup to prevent tissue damage.Fully retract vaginal cup to handle.Carefully remove device from vagina.Dont use excessive force to avoid traumatizing the vaginal canal.Upon removing, visually inspect vcare & patient to ensure the entire device was properly removed & no components were retained in patient.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer in brazil, the distributor reported issues with the vcare medium (34mm) cup, # 60-6085-201a, lot 202011021, that were experienced on (b)(6) 2021.Information received indicates ¿doctor reports that the manipulator broke in surgical procedure¿.It is noted the tip/piece did not fall off into the patient or surgical site.It is also noted there was no impact or injury to the patient.No other information was provided.As per the distributor, no clarification can be requested as the original reporter to the distributor has requested confidentiality.This report is being raised on the basis of previous fda filings for similar 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: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12983203
• MDR Text Key: 282112376
• Report Number: 1320894-2021-00440
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202011021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic