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Model Number UNKNOWN ENDO GIA INSTRUMENT |
Device Problems
Entrapment of Device (1212); Retraction Problem (1536)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/27/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic bilateral robotic nephrectomy procedure, after locking the device to cut the tissue, the device was able to fire until the end.Afterwards, the jaws did not open.The surgeon ultimately used more force to pull the black return knob back and the device was able to be released.A new handle and reload were used to resolve the issue.
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Manufacturer Narrative
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D10 concomitant product: unegiatri - unknown egia tri staple, lot# unknown 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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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 instrument locked on tissue and was difficult to retract.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.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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