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Model Number 8886848813 |
Device Problems
Device Slipped (1584); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/29/2022 |
Event Type
Injury
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Event Description
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According to the reporter, during a procedure, the device was fired but did not clip the vessel.The whole ligation clip fell off from the ligation clamp and fell into the patient cavity.The patient was bleeding during the surgery.The device was removed by the surgeon.
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Manufacturer Narrative
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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 laparoscopic cholecystectomy plus common bile duct exploration and lithotripsy, the device was fired but did not clip the vessel.The whole ligation clip fell off from the ligation clamp and fell into the patient cavity.It could not be detached from the reload, and the blood vessel was torn during the process of trying to detach it.It took more than 30 minutes due to the small space and difficult operation.The doctor then used the suture and other methods to ligate the remaining blood vessels to stop the bleeding and complete the surgery.
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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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Search Alerts/Recalls
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