COVIDIEN MFG DC BOULDER LIGASURE XP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number LXMJ44S |
Device Problem
Energy Output Problem (1431)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/14/2024 |
Event Type
Injury
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Event Description
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According to the reporter, during post operative, the device did not fully seal vessel.Patient was taken back for surgery due to internal bleeding caused by the device.Patient lost 2 l of blood and received transfusion the next day.Replaced with another device and it worked fine.
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Manufacturer Narrative
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D10 concomitant product: vlft10gen ft series energy platformx1 (serial#: unknown).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, post duodenal switch operative procedure, the ligasure did not fully seal vessel.Patient was taken back for surgery due to internal bleeding caused by the device.The patient have to be admitted to intensive care unit (icu).Patient lost 2l of blood and received transfusion the next day.Activation tone was heard, end tone was heard, and no error identified.The tissue bleeding occur from gastroepiploic artery.There was no any medications prior to the procedure, no patient received chemotherapy.Patient is ok and traveled home.Replaced with another device and it worked fine.
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Manufacturer Narrative
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Imf code was updated 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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