According to the reporter, during a laparoscopic cholecystectomy, when clamping the cystic duct, the 2 clips fell off and did not clamp the tissue.The user replaced with a new clip and used the same handle to resolve the issue.There was no patient injury.
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Evaluation summary: medtronic conducted an investigation based upon all information received.Two devices were available for evaluation.Visual inspection of the first cartridge noted that the clip was fully formed but not completely deployed from the cartridge.Functionally, a representative instrument was used for testing.The first cartridge was loaded into a representative instrument to complete the firing cycle; the pusher advanced properly and deployed the clip.The second cartridge was loaded into the representative instrument, the firing handle was actuated, and the clip formed properly onto the test media.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.This issue may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.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: failure to fully squeeze the handle may result in miss-formed clips which may result in incomplete closure and lack of hemostasis.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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