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Model Number LF1923 |
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 11/15/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during a procedure, start-up sound and the end sound rung, but the sealing was inadequate/partial.When approached the blood vessel in order to seal it, the device activated, but the output stopped and hemorrhaging occurred before the seal was completed.Bleeding occur after the blood vessel completely cut.Bleeding observed directly from the device's seal.When bleeding occurred, a completion tone sounded and the dissection operation was performed.After that, about 4 seals were outputted, but an error sound was heard and the output stopped for all before the sealing were completed.At that time, there were no objects other than tissue was clamped in between (visual confirmation).After several continuous attempts, the device was able to be used as normal, so continued to use the device and had no problem after that.
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Manufacturer Narrative
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D10 concomitant product: vlft10gen ft series energy platformx1 (serial#:(b)(6)).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 an error sound was heard and the sealing was inadequate/partial.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 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 video-assisted thoracoscopic surgery respiratory surgery, the start-up sound and the end sound rung, but the sealing was inadequate/partial.When approached the small blood vessel about 3 millimeters, in order to seal it the device activated, but the output stopped and hemorrhaging occurred before the seal was completed.When bleeding occurred, a completion tone sounded and the dissection operation was performed.Bleeding occurred after the cut even though it seemed properly sealed.Bleeding observed directly from the ligasure seal.After that, about 4 seals were outputted, but an error sound was heard and the output stopped for all before the sealing were completed.At that time, there were no objects other than tissue was clamped in between (visual confirmation).After several continuous attempts, the device was able to be used as normal, so continued to use the device and had no problem after that.Due to the small amount of bleeding, only the hemostasis of electrocautery was performed and blood transfusion was not performed.The problem occurred at the time of the first activation was performed.It the first activation when the event occurred, so cleaning was not performed before that.The customer decided that there is no problem with the generator.
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Manufacturer Narrative
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Additional information: g3 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 video-assisted thoracoscopic respiratory surgery, the start-up sound and the end sound rung, but the sealing was inadequate/partial.When approached the small blood vessel about 3 millimeters, in order to seal it the device activated, but the output stopped and hemorrhaging occurred before the seal was completed.When bleeding occurred, a completion tone sounded and the dissection operation was performed.Bleeding occurred after the cut even though it seemed properly sealed.Bleeding observed directly from the ligasure seal.After that, about 4 seals were outputted, but an error sound was heard and the output stopped for all before the sealing were completed.At that time, there were no objects other than tissue was clamped in between (visual confirmation).After several continuous attempts, the device was able to be used as normal, so continued to use the device with the same generator and had no problem after that.Due to the small amount of bleeding, only the hemostasis of electrocautery was performed and blood transfusion was not performed.The problem occurred at the time of the first activation was performed.It the first activation when the event occurred, so cleaning was not performed before that.
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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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