Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Two devices were available for evaluation.Visual inspection noted the distal end of the channel cover was cracked and clips was jammed under the channel cover.It was reported that the clip did not hold tightly to the vessel and detached.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue can occur if the user positions the instrument vertically and fires in air.This causes the fired clip to slip into the clip cartridge, preventing clips from loading properly.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: make certain that the tissue to be occluded fits completely within the confines of the clip or bleeding and leakage may result.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|