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

Catalog Number 60-6085-202A

Device Problem Inflation Problem (1310)

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

Event Date 01/29/2019

Event Type  malfunction  

Event Description

When testing the balloon for the v-care large, the balloon did not stay inflated.Multiple devices were opened and had the same issue.Noted, 2 different lot numbers.

• Brand Name: VCARE LARGE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 8366631
• MDR Text Key: 137259216
• Report Number: MW5084309
• 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
• 2 Devices were Involved in the Event: 1 2

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 201809101
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other