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Model Number 176625 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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According to the reporter, intraoperatively, the clips does not close.A new device was used to resolve the issue.There was no patient injury.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the jaws would not close upon actuation of the handle.The shaft was removed from the instrument body and the body was disassembled for visualization of internal components.The safety interlock channel lugs were broken.Due to the condition of the instrument, further functional evaluation could not be performed.It was reported that the clips does not close.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when an attempt is made to fire the instrument without first loading a clip by using the trigger.The safety interlock feature is designed to prevent the jaws from closing on a vessel in the absence of a loaded clip.If an attempt is made to forcibly fire the instrument while engaged in interlock, the lugs are designed to break as noted and the interlock feature continues to function as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: before attempting to squeeze the handle, be sure to first load a clip into the instrument jaws.If the jaw is empty, the instrument will not close.Always check to see if a clip is seated in the jaws prior to firing.When squeezing the handle, remove the finger from the trigger.Do not simultaneously pull the trigger and squeeze the handle as this may result in the firing of an unformed clip or jamming of the instrument.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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