MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	60-6085-203A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery for a robotic assisted hysterectomy, the doctor requested an extra large vcare and noticed that the balloon at the end of the device was leaking saline.The vcare was replaced and the surgery was continued.

• Brand Name: VCARE
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8349396
• Report Number: 8349396
• Device Sequence Number: 2254017
• Product Code: LKF
• UDI-Device Identifier: 10653405003816
• UDI-Public: (01)10653405003816
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/14/2019
• Report Date (Section F): 02/14/2019

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 Model Number: 60-6085-203A
• Device Catalogue Number: 60-6085-203A
• Device Lot Number: 201806181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1
• Patient Weight: 90
• Date Report Sent to FDA: 02/14/2019