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

Model Number 3200344

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Event Description

Vcare balloon leaked; occurred twice with two of the same product from the same lot #.The balloon was inserted into the vagina after the surgical vaginal prep.The leaking from the balloon was discovered before the surgical procedure was started.The failure had no affect on the patient as additional product was available for proceeding with the procedure.Manufacturer response for vcare, vcare large (per site reporter): product returned to manufacturer; online complaint form completed on the conmed website; unknown response at this time.

• Brand Name: VCARE PLUS, LARGE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd.; utica NY 13502
• MDR Report Key: 6724890
• MDR Text Key: 80641596
• Report Number: 6724890
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 3200344
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 201609131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1