According to the reporter, during a procedure, when the clip applier was loaded and performed clipping, clip could not be clipped on the blood vessel and came off meanwhile connecting to the cartridge.The part fell into the patient's cavity and was retrieved.A new clip applier from another package was able to clip without problem.There was no patient injury.
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination of the cartridges noted that the clip was fully formed but not completely deployed from the cartridges.Since the clinical instrument was not received the loading units were loaded into a pmv representative instrument and fired; the pushers advanced properly and deployed the clips.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 clip not fully deployed condition may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.The root cause of the observed damage was misuse of the product 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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