According to the reporter, during procedure, after approximate 30 minutes device stopped working.When the surgeon was using the dissector could not be used anymore to cut the tissue.No part of the dissector broke nor detached, nothing fell into patient's cavity.Replaced with a new device and it worked fine.There was no patient injury.Medtronic's initial evaluation of the incident device had a fractured waveguide.The tip was returned.
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the disposable device revealed that the dissector had a fractured waveguide.The tip was returned.It was reported that the device device cutting issue, and there was no activation during procedure.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur due to continued use after it may have come in contact with a metallic object.Use after damage can cause the cracked waveguide to break off.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in product damage, such as a broken blade.Pieces of a broken blade may fall into the surgical cavity causing unintended tissue damage.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|