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Model Number SIGTRSB45AXT |
Device Problems
Misfire (2532); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant products: egiaushort, egiaushort endogia ultra univ sht stap (lot#:p2g0541) unknown egia su, unknown endo gia sulu (lot#:unknown) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload was partially fired and the interlock was engaged.The sled and staples were visible at the 0.5cm cut line.The jaw of the reload was open.Staple pushers were visible at the 1cm cut line.The proximal sutures were cut properly.The distal sutures were returned intact.The reinforcement materials were cut at the 0.5cm cut line.It was reported that the instrument did not fire.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 the laparoscopic partial thoracoscopic lung resection for pneumothorax, after using the reinforce reload twice to resect the bulla, an attempt was made to use the third reinforce reload, but the handle was stiff and it could not be fired.The stapler was reset back on the tissue and squeeze the handle to fire but the handle was idling and could not be fired.The handle was replaced with a new one and used the same reload without any problems.After that, the fourth pulmonary resection was performed using another reinforce reload but the anchoring suture at the tip did not detached, so it was cut with a pair of scissors.There was no patient injury.Medtronic's initial evaluation of the incident found that the reload was partially fired and the interlock was engaged.
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Search Alerts/Recalls
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