|
Model Number LF1923 |
Device Problems
Energy Output Problem (1431); Difficult or Delayed Activation (2577)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/03/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
D10 concomitant product: vlls10gen, vlls10gen ls series vessel sealing gen, (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.
|
|
Event Description
|
According to the reporter, during procedure, the handpiece had no seal (no evidence of energy delivery) and was difficult to activate.There was no patient injury.
|
|
Event Description
|
According to the reporter, during open procedure, the handpiece had no seal (no evidence of energy delivery) and was difficult to activate.There was a re-grasp alert and error tone heard.The jaws were cleaned when the handpiece is not at use.There was no patient injury.
|
|
Manufacturer Narrative
|
Additional information: b5, d9, g3, h3, h6 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.
|
|
Manufacturer Narrative
|
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found eschar build up on the jaws and in the knife track of the device.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 cut of the device was tested on a silicone test strip and yielded unacceptable results.The knife blade was inspected under high magnification, however no damage was noted to the blade's edge.The heel gap of the device was measured and it was found to be within specification.The device was detected by the lab generator, however the device was unable to initiate nor complete seals.No alarms were heard and no energy was delivered to the saline soaked gauze pad.The device was disassembled for further analysis.The purple cord plug was severed at the heel of the device.It was reported that the handpiece had no seal and the device was difficult to activate.The reported issues were 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.The evaluation detected an unreported condition not related to the reported condition of improper cleaning.The product analysis noted evidence that the device was not used as intended.The instructions included with this device provide the following guidance: keep the instrument jaws clean.Build up of eschar may reduce sealing or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|
|
|