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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM (34MM) CUP

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CONMED CORPORATION VCARE MEDIUM (34MM) CUP Back to Search Results
Model Number 60-6085-201A
Device Problem Detachment Of Device Component (1104)
Patient Problem Uterine Perforation (2121)
Event Date 07/21/2017
Event Type  Injury  
Manufacturer Narrative
Conmed was unable to evaluate the device as it was discarded by user facility; therefore, the reported detachment of the device component is unable to be verified.A review of the manufacturing documents from the device history record has verified the devices were produced according to current and approved procedures and material specifications.The products released for distribution were found to have met all specifications prior to shipment.In this lot of (b)(4) units, this is the only complaint against this lot.A 2-year product history review revealed a total of 2 complaints for this device and failure mode combination.In that same timeframe (b)(4) units have been sold worldwide making the occurrence rate for this reported failure mode (b)(4).Based on this information this failure is acceptable when weighed against the benefits of use of this device.The instruction for use advice the user of the following when using this device: visually inspect vcare on removal from the patient to verify that the device is intact and all forward components have all been retrieved from the patient.Should uterine perforation and/or bleeding occur immediately follow the clinically indicated procedure to establish hemostasis.Improper use of this or any intrauterine instrument can result in perforation of the uterine wall and subsequent bleeding.This incident has been escalated and will be investigated further due to the reported patient injury.
 
Event Description
A conmed sales representative reported on behalf of a user facility that during the colpotomy portion of a robotic assisted total hysterectomy, the handle of the vcare became detached from the shaft while rotating the device left to right.This alleged device malfunction caused the surgical assistant to push the device forward more than intended, which led to a perforated uterus.Additionally, the user facility reported no delays in procedure and the perforation caused minimal bleeding that was resolved with cauterization.The complaint device was discarded and will not be returned for evaluation.This report is being raised on the basis of an alleged device malfunction which caused a patient injury.
 
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Brand Name
VCARE MEDIUM (34MM) CUP
Type of Device
VCARE
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
lindsey sheppard
525 french road
utica, NY 13502-5994
7273995209
MDR Report Key6785468
MDR Text Key82401517
Report Number1320894-2017-00177
Device Sequence Number1
Product Code LKF
UDI-Device Identifier10653405003793
UDI-Public(01)10653405003793(17)190123(10)201701231
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 company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/23/2019
Device Model Number60-6085-201A
Device Catalogue Number60-6085-201A
Device Lot Number201701231
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/26/2017
Initial Date FDA Received08/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2017
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 Age57 YR
Patient Weight89
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