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

Model Number 606085202A

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

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

The balloon closest to the handle was not inflating due to a leak in the equipment.The device was removed and new equipment opened, no harm or delay.Fda safety report id # (b)(4).

• Brand Name: VCARE LAREG
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 10894393
• MDR Text Key: 218500578
• Report Number: MW5098045
• Device Sequence Number: 1
• Product Code: LKF
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 606085202A
• Device Lot Number: 202007071
• 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: 51 YR