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According to the reporter during an open lobectomy procedure, while trying to clip the pulmonary vein, the clip was not able to be loaded properly when a blank firing was performed outside of the body and an attempt was made to reload.The clip was found to be loaded with bent condition when the actual device was checked.To resolve the issue, it was ligatured by a thread.There is no patient injury.
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H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that clips can be seen jammed under the channel cover.Functionally, the jammed clips were removed; as the second clip was be ing removed, the next clip loaded into the jaw and was fired with proper formation.The instrument was first test fired once in air so that the clip formation could be observed.The remaining clips were fired on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and returned to the open position.Each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaws from approximating.It was reported that the clips did not load properly into the jaws as expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when an attempt is made to fire the instrument without fully releasing the handle after the previous firing.When the full firing stroke is not completed, the next clip is not loaded into the jaw and any subsequent firing attempts cause clips to jam in the channel.It was also reported that the device had bent out of its intended shape.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: ensure that the handles are squeezed together firmly as far as they will go.Failure to squeeze the handles completely can result in clip malformation and possible bleeding or leakage.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.
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