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Model Number 60-6085-201A |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/23/2022 |
Event Type
Injury
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Event Description
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The customer reported that the device 60-6085-201a, vcare 200a - medium, was being used during a robotic hysterectomy procedure on (b)(6) 2022 when it was reported that ¿vcare device fell apart into 3-4 pieces inside the patient's body." the procedure was completed without the use of an alternate device and there was no delay reported.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of surgical, medical intervention, or hospitalization for the patient.This report is being raised on the basis of injury due to possible retained device.
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Manufacturer Narrative
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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.
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Event Description
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The customer reported that the device 60-6085-201a, vcare 200a - medium, was being used during a robotic hysterectomy procedure on (b)(6) 2022 when it was reported that ¿vcare device fell apart into 3-4 pieces inside the patient's body." the procedure was completed without the use of an alternate device and there was no delay reported.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of surgical, medical intervention, or hospitalization for the patient.This report is being raised on the basis of injury due to possible retained device.
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Manufacturer Narrative
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The reported event of ¿device fell apart inside the patient¿ is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A 2 year lot history review was conducted and found 2 events for this lot number and failure mode.A dhr review found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 144 complaints, regarding 179 devices, for this device family and failure mode.During this same time frame 550,400 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 0.0003.Per the instructions for use, the user is advised to 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 counter-clockwise (anti-clockwise) and retract to the handle.Swipe finger around the edge of the vaginal cup to separate tissue from the cup to prevent tissue damage.Fully retract the vaginal cup to the handle.Carefully remove the device form the vagina.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal.Upon removing the vcare, the surgeon should visually inspect the vcare device and the patient to ensure 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.
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Search Alerts/Recalls
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