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

Catalog Number	60-6085-200A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
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.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer, that the 60-6085-200a, vcare 200a ¿ small was being used during a robotic hysterectomy procedure on (b)(6) 2024 date when it was reported ¿the tip of vcare manipulator broke off during removal of the item after the colpotomy was completed.The surgeon removed the piece without any issue.No harm occurred to the patient and there was no delay.¿.The procedure was completed without the use of an alternate device and no delay was reported.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-6085-200a in opened original packaging.Lot number was verified.Performed a visual inspection, the device was returned disassembled with the balloon, cervical cup and blue cone detached.There is evidence of adhesion at the distal tip of the shaft where the balloon was attached.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be lot variation within the heat shrink material adhesive properties.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.(b)(4).Per the instructions for use, the user is advised to 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 counter-clockwise (anti-clockwise) and retract to the handle.A.Swipe finger around the edge of the vaginal cup to separate the 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 to avoid traumatizing the vaginal canal.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 60-6085-200a, vcare 200a ¿ small was being used during a robotic hysterectomy procedure on (b)(6) 2024 date when it was reported ¿the tip of vcare manipulator broke off during removal of the item after the colpotomy was completed.The surgeon removed the piece without any issue.No harm occurred to the patient and there was no delay.¿.The procedure was completed without the use of an alternate device and no delay was reported.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE 200A - SMALL
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19086143
• Report Number: 1320894-2024-00098
• Device Sequence Number: 20608613
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)251224(10)202312251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 12/24/2025
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202312251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic