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Model Number 176657 |
Device Problems
Mechanical Problem (1384); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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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.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the clips not loading properly and there was an issue on clip formation.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: confirm that the clip is positioned within the jaws and is free of other clips or obstructions before squeezing the handles to close the clip.Failure to squeeze the handle as far as it will go may result in clip malformation and possible bleeding or leakage.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, during placement of the clips, the first clip did not load, then after a few attempts, it worked.The first clip came out crooked, like it was blocking everything.The first clip applier was still used, but the surgeons till opened a second clip applier to be sure.No patient injury.
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Search Alerts/Recalls
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