According to the reporter, during the insertion step in a laparoscopic sleeve gastrectomy, the trocar made a strange noise and had a damaged and disengaged seal.There was also an air leak from the seal.Another product was used to complete the procedure.There was no patient injury.
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H3 evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned products noted: that the circular seal on one of the devices was cut.The trocars, cannulas, and duckbill seals appeared intact.The obturators were received.A functional evaluation found that the devices passed an air leak test.The duckbill seals pass however the instruments seals leak during manual manipulation using a device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cut in the circular seal may occur when contact is made with a sharp surgical instrument during a clinical application.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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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