COVIDIEN MFG DC BOULDER UNKNOWN GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
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Model Number UNKNOWN GENERATOR |
Device Problems
Device Alarm System (1012); Energy Output Problem (1431)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/25/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during a sleeve gastrectomy, while sealing a slim abdominal fat, in the first 10 minutes of the ligasure surgery, the device did not clot correctly then began coagulating and no seal was done correctly.There was a re-grasp alert, an end tone was heard, but no evidence of any energy delivery was observed.The procedure was completed but the patient had a bleeding after the procedure, but no blood transfusion was necessary.
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Manufacturer Narrative
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D10 concomitant device: lf1937, jaw lap lf1937 ligasure maryland 37cm (lot#31940090x) 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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Manufacturer Narrative
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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, during a sleeve gastrectomy, while sealing a slim abdominal fat, in the first 10 minutes of the ligasure surgery, the device did not clot correctly then began coagulating and no seal was done correctly.There was a re-grasp alert, an end tone was heard, but no evidence of any energy delivery was observed.The procedure was completed but the patient had a bleeding in the vessels of abdominal fat, but no blood transfusion was necessary.A sonicision was used to resolve the bleeding and complete the procedure.
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Search Alerts/Recalls
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