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U.S. Department of Health and Human Services

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

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CONMED CORPORATION VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM; VCARE UTERINE MANIPULATOR Back to Search Results
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.
 
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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 Key3555846
MDR Text Key19732903
Report Number1320894-2014-00001
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071907
Number of Events Reported1
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 Date10/31/2015
Device Catalogue Number60-6085-201
Device Lot Number1310141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2013
Initial Date FDA Received01/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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