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Model Number EGIA60AMT |
Device Problems
Device Difficult to Setup or Prepare (1487); Misfire (2532); Component or Accessory Incompatibility (2897)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic sleeve gastrectomy procedure, at the time of loading the fifth reload, the device was unable to load.A new handle and reload were used to resolve the issue.There was no patient injury.Afterwards, the defective handle was loaded with a new reload and was able to fire.It was also observed that the fifth reload's lock ring was was out of position.The fifth reload was then loaded again on the same handle and was able to load and fire, but the staples were partially fired.
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Manufacturer Narrative
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D10 concomitant product: egiaustnd - egiaustnd endogia ultra univ std stap, lot# p3c0149 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted in images 1,2,3,4,5,6,7,8,9,10,11, and 12, the lock ring was noted to be out of position.Staple pushers were up distally.Formed staples could be seen in the jaws of the reload.It was reported that the device was difficult to load and the lock ring was out of position.The reported issues were confirmed.The most likely cause could not be established from the information available.It was also reported that the device was partially fired.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the reload was fully fired with the interlock engaged and the jaws were open.Functionally, the reload was loaded into the subject instrument.The interlock was overridden and the reload was cycled without hesitation or binding.Test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that the device partially fired.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.It was also reported that the device was difficult to load and the lock ring was out of position.The reported issues were confirmed.The most likely cause could not be established from the information available.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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Search Alerts/Recalls
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