MAUDE Adverse Event Report: CONMED CORPORATION VCARE UTERINE MANIPULATOR

Model Number 60-6085-201A

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2017

Event Type  malfunction  

Event Description

The balloons on both conmed corporation vcare medium uterine manipulators would not inflate when trialed prior to use.The devices were noted to be from two different lot #s.

• Brand Name: VCARE UTERINE MANIPULATOR
• Type of Device: VCARE UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 6705830
• MDR Text Key: 79933922
• Report Number: MW5070922
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/10/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2019
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201703201
• 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