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

Catalog Number 60-6085-202A

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

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

Event Date 01/22/2019

Event Type  No Answer Provided  

Event Description

When the surgeon inflated the balloon, the balloon cuff slides down on the 1st device, the 2nd device the cuff would not remain inflated.Five cc of air was inserted into the balloon and it was noted that air was coming through the plastic seal which connected to the v-care shaft.Testing was done prior to insertion into the patient.No patient harm a new device was used.

• Brand Name: VCARE LARGE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 8366664
• MDR Text Key: 137379233
• Report Number: MW5084311
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 201809241
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1