Model Number UNKNOWN LIGASURE INSTRUMENT |
Device Problems
Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446); Unspecified Hepatic or Biliary Problem (4493)
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Event Date 11/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Literature: title: effects of intraoperative blood loss during liver resection on patients¿ outcome: a single-center experience source: turk j med sci (2021) 51: 1388-1395.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 literature source of study performed between january 2007 and october 2018, a retrospective study analyzed outcomes of patients who underwent liver resection.The liver was transected via clamp crushing and ligasure.There were 257 patients in the study and complications included: bleeding, biliary leak and surgical site infection.Biliary leak was treated with relaparotomy or percutaneous drainage.Reoperations were required for postoperative bleeding and wound dehiscence due to surgical site infection.Transfusions were reported.
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Manufacturer Narrative
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New information has been received pertaining to the event.Follow-up from the author confirms that the adverse events reported in the article were not related to a medtronic device/product.This event has been reassessed and found to be a non-reportable event.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 literature source of study performed between (b)(6) 2007 and (b)(6) 2018, a retrospective study analyzed outcomes of patients who underwent liver resection.The liver was transected via clamp crushing and ligasure.There were 257 patients in the study and complications included: bleeding, biliary leak and surgical site infection.Biliary leak was treated with relaparotomy or percutaneous drainage.Reoperations were required for postoperative bleeding and wound dehiscence due to surgical site infection.Transfusions were reported.Medical safety reviewed the follow-up information received.Follow-up from the author confirms that the adverse events reported in the article were not related to a medtronic device/product.
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Search Alerts/Recalls
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