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

Model Number 606085202A

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Event Description

The balloon was not inflating due to a leak in the equipment.The device was removed and a new piece of equipment was opened.There was no harm to the patient and no delay.Fda safety report id# (b)(4).

• Brand Name: VCARE LARGE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 10448199
• MDR Text Key: 204452562
• Report Number: MW5096227
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: 606085202A
• Device Lot Number: 202001201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 73