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

Catalog Number 60-6085-201

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2015

Event Type  malfunction  

Event Description

The surgeon inserted the vcare device into the patient.When inflating the balloon with saline, it was noted that the balloon had popped.The device was removed and replaced with a second vcare.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 5165029
• MDR Text Key: 28837086
• Report Number: 5165029
• 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: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 60-6085-201
• Other Device ID Number: MEDIUM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR