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Model Number 176630 |
Device Problems
Break (1069); Display or Visual Feedback Problem (1184); Detachment of Device or Device Component (2907); Mechanics Altered (2984)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a distal pancreatectomy, two clips were fired.However, when cutting between the clips with an ultrasonic coagulation or cutting device, the clip burst into two and fell into the patient¿s cavity.The clip that burst open was collected.The ultrasonic blade had hit the clip certainly.After that, the device was used without problems.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found damage to the instrument consistent with application over an obstruction.The instrument was partially applied with four clips remaining.The clip counter was no longer active.No visual abnormalities were observed.A clip in two pieces was received and the clip was burnt at the apex.Functional testing noted that the instrument was applied to appropriate test media.The instrument cycled without binding.Clips advanced into the jaws, formed properly, and were held securely in place after full formation was achieved and the firing handle was released.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.It was reported that the clips did not load properly into the jaws as expected, a clip broke into pieces and a component disengaged from the device into the surgical cavity.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if a clip came into contact with a cautery device during clinical application.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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Event Description
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According to the reporter, during a distal pancreatectomy, the device was able to fire a single clip normally.However, when cutting between the clips with an ultrasonic coagulation or cutting device, the clip burst into two and fell into the patient¿s cavity and were retrieved with laparoscopic forceps.It was stated that the ultrasonic blade had hit the clip certainly.After that, the device was used without problems.There was no patient injury.
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Search Alerts/Recalls
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