MAUDE Adverse Event Report: CONMED CORPORATION VCARE, LARGE (37MM) CUP

Catalog Number 60-6085-202

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 12/30/2016

Event Type  Death  

Manufacturer Narrative

The device will not be returned for evaluation; therefore, any device issue, lot and catalog number cannot be verified.A review of the manufacturing documents is unable to be completed due to no existing records for the reported lot number.A historical review of complaint data revealed this incident to be the only complaint in the past two years for this device and failure mode combination.In the same timeframe, (b)(4) units have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent.The clinical data report for this device states that when used under the conditions and for the purposes intended by the manufacturer, undesirable side effects during the use of conmed vcare, under normal conditions of use, are acceptable when weighted against the benefits to patients.For the reported incident, the vcare device was not used as intended nor under normal conditions of use.The instructions for use provides the following warnings.Do not inject dyes/marking fluids rapidly as high intrauterine pressure can develop.Injection of such fluids can result in expulsion of the device from the uterus, spasm of the fallopian tubes or vascular extravasation.Use slow and steady pressure for injection of any appropriate dye or marker fluid.Do not attach other devices or lines other that the syringe to inject contrast medium to the injector port.As defined in the (b)(6) medical literature, "the (b)(6) side-kick uterine manipulator holder is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures." it warns, "do not attach a gas line to a uterine manipulator, extreme danger." also, "to avoid confusion, make these connections [gas line connections] prior to inserting the manipulator into the patient." based on the information provided, the potential cause of this issue is user related.Due to the severity of this reported incident, an investigation has been initiated.

Event Description

Conmed became aware of an event involving a vcare and a (b)(6) side kick through a (b)(6) report filed under (b)(6) medical.During a robotic hysterectomy, the patient received an air emboli to the heart due to the nitrogen gas being connected to the vcare dye injection port.When this was noticed the nitrogen gas was turned off.Despite heroic measures to resuscitate the patient, the patient passed away.This reported is being raised based on a patient's death.

• Brand Name: VCARE, LARGE (37MM) 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: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7051269
• MDR Text Key: 92712672
• Report Number: 1320894-2017-00260
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 201303091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death