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

Catalog Number	60-6085-202A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of his customer that the 60-6085-202a, vcare 200a ¿ large was being used in an unnamed surgical procedure on (b)(6) 23, ¿and when the surgeon went to instill the balloon, it broke completely off¿.A good faith effort to obtain further information about the procedure or patient was unsuccessful.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-6085-202a in original opened package.Lot number was verified.Performed a visual inspection, the complaint was confirmed.The pilot balloon was completely disassembled.While a root cause cannot be identified, based on the evaluation and the photographic evidence a likely cause is that excessive force was applied to the pilot balloon cord.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 lot history review shows this is the only such occurrence for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 10 reports, regarding 10 devices, for this device family and failure mode.During this same time frame 578,568 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 0.00002.Per the instructions for use, the user is advised: 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.Do not inject dyes or marker fluids into the pilot balloon.Dyes or marker fluids should only be injected through the injector port on the rear of the handle.Do not attach other devices or lines to the pilot balloon.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of his customer that the 60-6085-202a, vcare 200a ¿ large was being used in an unnamed surgical procedure on (b)(6) 2023, ¿and when the surgeon went to instill the balloon, it broke completely off¿.A good faith effort to obtain further information about the procedure or patient was unsuccessful.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE 200A - LARGE
• Common Device Name: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 17951182
• Report Number: 1320894-2023-00215
• Device Sequence Number: 7530447
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)250319(10)202303201
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2025
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202303201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic