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Model Number 133650 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
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 harvest of the great saphenous vein as coronary artery bypass grafting (cabg), open procedure, the device was misfiring and unable to be used.The surgeon was able to squeeze the handle.Individual self-loading liga applicators used in place.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 instrument was partially applied with eleven remaining clips.The distal end of the channel cover was intact.Microscopic inspection of the jaws revealed acceptable jaw co-planarity.Functionally, the instrument was cycled, and the pusher did not load the clip.The pusher bar was observed to be damaged.It was reported that the clips were not loading properly.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the jaws of the instrument are constrained or with a side load to the jaws while attempting to fire a clip.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: do not excessively twist or torque the jaws.Excessive twisting or torqueing the jaws may dislodge clip from the jaws or cause clip malformation after jaw closure.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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