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Model Number SIGTRSB60AMT |
Device Problems
Failure to Fire (2610); Component or Accessory Incompatibility (2897)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during an open urology, there was a problem loading the device; that stapler was opened and loaded by an agency nurse, but it was done incorrectly.It was noted that the stapler was able to be cycled, it would open and closed.The surgeon tried to fire the device, device was clamped onto tissue at one point but when it did not fire, it was then removed from the tissue and it was not locked onto the tissue.The surgeon could press the green button but could not squeeze the handle.The device was not used in the patient.Another stapler from another company was used to resolve the issue.There was no patient injury.
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Manufacturer Narrative
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D10 concomitant product: egiaushort - egiaushort endogia ultra univ sht stap, lot# p3g0347 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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