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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION VCARE SMALL (31MM CUP); UTERINE MANIPULATOR

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CONMED CORPORATION VCARE SMALL (31MM CUP); UTERINE MANIPULATOR Back to Search Results
Catalog Number 60-6085-200
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/12/2017
Event Type  malfunction  
Manufacturer Narrative
The "damaged/used" vcare uterine manipulator was not returned for evaluation of "vcare was used on patient and upon removing device from the patient's uterus it broke into 3 pieces." however, photographs of the device were provided which show that the cervical cone and vaginal cone had completely detached from the device.Therefore, this complaint is confirmed it is noted that the intrauterine balloon appeared to be intact and remained attached to the device, along with the locking mechanism, handle and pilot balloon.The cause of this complaint cannot be conclusively determined without examination of the complaint device.However, based on the information received and photographic evaluation, this complaint may be use related.The device was manufactured 08-feb-2016.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident.Of the lot containing b)(4) units, there were no other similar complaints received.B)(4).To date, there has been no patient long term adverse effects reported regarding any of the reported incidents.The vcare uterine manipulator is a disposable, single-use device for manipulation of the uterus and cervix in surgical and diagnostic procedures.The device consists of a manipulator tube having an inflatable balloon at its proximal end and an anatomically configured cannula/handle for maintaining proper attitude of the uterus at the distal end.The vcare incorporates a system of cup-like elevators to provide manipulation of the uterus, and retraction and elevation of the cervix.The conmed vcare is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (lavh), total laparoscopic hysterectomy (tlh), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once a colpotomy is performed.To reduce the risk of component detachment and patient injury, the instruction for use (ifu) provides the following warnings and precautions: -prior to removal of the device, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.-do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.-vaginal delivery of a large uterus may result in patient injury.Methods should be used to reduce the size of the uterus prior to removal through the vaginal canal.-visually inspect the vcare device on removal from the patient to verify that the device is intact and all forward components (intrauterine balloon; cervical cup; vaginal cup; locking assembly; and thumbscrew) have all been retrieved from the patient.
 
Event Description
As reported by the user facility, during a laparoscopic abdominal hysterectomy on b)(6) 2017 a "vcare was used on a patient and upon removing device from the patient's uterus it broke into three (3) pieces." further information from the facility revealed that the vcare came apart at the end of the procedure as they were removing the uterus from the patient."the green cup detached and was inside the patient.The surgeon retrieved the green cup from inside the patient." all three (3) pieces were retrieved and verified by the surgeon.There was no patient injury or surgical delay.This incident is being reported based on the potential for injury with recurrence.
 
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Brand Name
VCARE SMALL (31MM CUP)
Type of Device
UTERINE MANIPULATOR
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer (Section G)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer Contact
kimber boss
525 french road
utica, NY 13502-5994
3156243441
MDR Report Key6279985
MDR Text Key65854216
Report Number1320894-2017-00014
Device Sequence Number1
Product Code LKF
UDI-Device Identifier00653405061796
UDI-Public(01)00653405061796(17)18020(30)1(10)201602081
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K071907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 01/24/2017
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 Date02/07/2018
Device Catalogue Number60-6085-200
Device Lot Number201602081
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/12/2017
Initial Date FDA Received01/26/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age43 YR
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