According to the reporter, during a laparoscopic obesity surgery, the clip has been installed on the staple line, the handle was squeezed, the clip was unable to load properly into the jaws, when the handle was fired for the clip to be thrown, double clips coming to the jaw in a single clamp while one is closing, the other clip had fallen into the patient cavity and was retrieved with a grasper.A new product was used to resolve the issue.There was no patient injury.
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Evaluation summary: medtronic conducted an investigation based upon all information received.Three devices and a photo were available for evaluation.V isual inspection noted unformed clips.Functionally, the three instruments were applied to appropriate test media.The three instruments cycled without binding.All the clips advanced into the jaws, formed properly, and were held securely in place after full forma tions were achieved and their firing handles were released.When the three cartridges were empty, the interlocks engaged to prevent the jaws from approximating.It was reported that the clips did not load properly into the jaws as expected, the clip did not hold tightly to the vessel and detached, the clip(s) were unintentionally ejected from the jaws, a component disengaged from the device into the surgical cavity, and the device fired two staples or tacks rather than just one.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.Replication of the unformed clip condition may occur when the handle is not cycled completely in one continuous cycle.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: when firing the instrument, squeeze the handle as far as it will go.Failure to squeeze the handle completely may result in clip malformation and possible bleeding or leakage.In addition; when squeezing the handle, remove finger from trigger.Do not simultaneously pull the trigger and squeeze the handle as this may result in the firing of an unformed clip or jamming of the instrument.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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