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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED UTICA VCARE 200A - SMALL; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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CONMED UTICA VCARE 200A - SMALL; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Catalog Number 60-6085-200A
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2022
Event Type  malfunction  
Event Description
The sales representative reported on behalf of the customer that the, 60-6085-200a, vcare 200a - small was being used on (b)(6) 2022 during a hysterectomy procedure and the ¿v-care fell apart and into several pieces during the uterus extraction portion of a hysterectomy¿.There was no injury or impact to the patient or user.The procedure was completed without an alternate device.Surgery stopped and search for pieces in the patient ensued.All pieces were collected.There was a 30 minute delay.The patient is ok.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Manufacturer Narrative
Reported event is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as no lot number was provided.A device history record review cannot be conducted as a valid lot number was not provided.A two-year review of complaint history revealed there has been a total of 59 reports, regarding 70 devices, for this device family and failure mode.During this same time frame 509,312 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.Per the instructions for use, the user is advised the following: re-attach the syringe to the luer connector at the end of the pilot balloon; fully aspirate the air from the intrauterine balloon to deflate.This will allow the intrauterine balloon to be removed from the uterus.Unlock the locking mechanism by turning the thumbscrew counterclockwise (anti-clockwise) and retract to the handle.Swipe finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Fully retract the vaginal cup to the handle.Carefully remove the device from the vagina.Do not use excessive force to avoid traumatizing the vaginal canal.Upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The sales representative reported on behalf of the customer that the, 60-6085-200a, vcare 200a - small was being used on (b)(6) 2022 during a hysterectomy procedure and the ¿v-care fell apart and into several pieces during the uterus extraction portion of a hysterectomy¿.There was no injury or impact to the patient or user.The procedure was completed without an alternate device.Surgery stopped and search for pieces in the patient ensued.All pieces were collected.There was a 30 minute delay.The patient is ok.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand Name
VCARE 200A - SMALL
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CONMED UTICA
525 french rd
utica NY 13502
Manufacturer (Section G)
CONMED UTICA
525 french rd
utica NY 13502
Manufacturer Contact
robin drum
11311 concept blvd
largo, FL 33773
8653881978
MDR Report Key14352822
MDR Text Key291363286
Report Number1320894-2022-00093
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/14/2022
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 Catalogue Number60-6085-200A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/15/2022
Initial Date FDA Received05/11/2022
Supplement Dates Manufacturer Received06/06/2022
Supplement Dates FDA Received06/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
Patient EthnicityNon Hispanic
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