MAUDE Adverse Event Report: CONMED UTICA VCARE; 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	09/05/2024
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
The sales representative reported on behalf of the customer that the 60-6085-202a, lg,uterine manipulator was being used on (b)(6) 2024 and ¿we were doing a robotic hysterectomy today.After the uterus was all dissected, the surgeon pulled on the vcare handle and the ¿cup¿ broke of inside the patient.There was 4 pieces that we retrieved.Had to fish parts of vcare and confirm all parts were found.¿.The procedure was completed without an alternate device.There was a 20 minute delay.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 opened original packaging.Lot number was verified.Performed a visual inspection, the device was returned in multiple pieces.There is evidence of proper adhesion at the distal tip of the shaft where the uterine balloon was connected.The green cervical cup was not returned with the device.A root cause cannot be determined; however, based upon evaluation of the device; a possible cause of this event could be the use of excessive force during removal of the device from the patient.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 40 reports, regarding 44 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 (b)(4).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.Unlock the locking mechanism by turning the thumbscrew counterclockwise (anti-clockwise) and retract to the handle.A) swipe finger around the edge of the vaginal cup to separate tissue from the cup to prevent tissue damage.B) fully retract the vaginal cup to the handle.Carefully remove the device from the vagina.Do not use excessive force.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6085-202a, lg, uterine manipulator was being used on (b)(6) 2024 and ¿we were doing a robotic hysterectomy today.After the uterus was all dissected, the surgeon pulled on the vcare handle and the ¿cup¿ broke of inside the patient.There was 4 pieces that we retrieved.Had to fish parts of vcare and confirm all parts were found.¿.The procedure was completed without an alternate device.There was a 20 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20368381
• Report Number: 1320894-2024-00266
• Device Sequence Number: 3689662
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)251022(10)202310231
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 10/22/2025
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202310231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic