MAUDE Adverse Event Report: CONMED CORPORATION VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM; VCARE UTERINE MANIPULATOR

Catalog Number 60-6085-201

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/11/2013

Event Type  malfunction  

Event Description

It was reported to conmed that, "while extracting the v-care from the patient vagina, both the blue and green cups broke off the device and were left in the patient's vaginal canal.Surgeon was able to extract the retained pieces." it was also reported that there was no patient injury.

Manufacturer Narrative

This is an fda reportable event due to a sentinel event reported on medwatch 1320894-2012-00099.The actual device has been discarded by the end-user facility; therefore, will not be evaluated by conmed corporation.On completion of the quality engineering investigation of this reported incident a supplemental report will be filed.Device discarded by end-user.

• Brand Name: VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM
• Type of Device: VCARE UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer Contact: stephen casanova ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3555846
• MDR Text Key: 19732903
• Report Number: 1320894-2014-00001
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 1310141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1