MAUDE Adverse Event Report: CONMED CORP. V-CARE UTERINE MANIPULATOR

Model Number 60-6085-200

Device Problem Break (1069)

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

Event Date 06/06/2017

Event Type  malfunction  

Event Description

Conmed small v-care uterine manipulator inserted into patient.Upon inflating the balloon and removing syringe, physician noticed that the valve was broken from the device.Defective device removed from patient and sterile field.

• Brand Name: V-CARE UTERINE MANIPULATOR
• Type of Device: UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORP.; utica NY 13502
• MDR Report Key: 6696607
• MDR Text Key: 79645019
• Report Number: MW5070859
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2018
• Device Model Number: 60-6085-200
• Device Catalogue Number: 60-6085-200
• Device Lot Number: 201608291
• 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: 65 YR