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Evaluation summary: medtronic conducted an investigation based upon all information received.One opened and four sealed samples were available for eval uation.A photo was also provided.Visual inspection found that the opened instrument was partially applied with eleven clips remaining.The clip counter was no longer active.Two malformed clips were received, along with a component.The four sealed instruments were sealed with the full complement of sixteen clips each.No visual abnormalities were observed with the returned samples.Functional testing noted that the returned samples were applied to appropriate test media.The samples cycled without binding.Clips advanced into the jaws, formed properly, and were held securely in place after full formation were achieved and the firing handle were released.When the cartridges were empty, the interlock engaged to prevent the jaws from approximating.The open instrument was disassembled to inspect internal components to see if the component received came from the instrument, and no abnormalities were observed.It was reported that the clips did not close completely and were malformed, and a component disengaged from the device into the surgical cavity.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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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