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Model Number 176630 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
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, during a laparoscopic cholecystectomy procedure, the surgeon initially experienced difficulty loading the clip applier.When the clip applier was applied to the cystic artery and duct, the clips were not formed correctly and were loose.The clips fell into the patients cavity and were removed from the patient using graspers.Another clip applier 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 an excessive amount of dried bodily fluid was observed in the shaft and on the clip track.This was preventing clips from properly loading into the jaws of the instrument.It was reported that the clips did not load properly.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if bodily fluid builds up inside the shaft of the instrument.This may interfere with clip loading and prevent the instrument from firing.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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