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Model Number LF1937 |
Device Problems
Failure to Cut (2587); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: vlft10gen, 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 reporter, during laparoscopic nephrectomy procedure, start-up sound and ending sound were heard from device.There was activation tone but no regrasp noted.Doctor stated that there was no problem with the sealing but the knife was not cutting properly.Photo received showed that the knife blade was exposed.A new device was used with the same generator and it worked fine.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted minor damage to the device's knife track.Functionally, the device's jaw opening and closing mechanism was functioning properly.The weld integrity of the device was inspected and was found to be within specification.The knife trigger was stiff at press but the blade would advance and retract once additional force was applied to the trigger.The heel gap of the device was measured and it was found to be within specification.The device would produce an instant re-grasp alarm when activation was attempted.The device was disassembled and it was found that the device's red wire had come out of the pull tube and was severed.The knife pull would get stuck on the wire when attempting to advance and retract.The damage to the knife track was likely caused by the knife blade, due to the blade being difficult to open and close.It was reported that the knife was not cutting properly.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Improvements have been initiated to mitigate this condition.The event had foreseen risk and is included in a data monitoring plan.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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