|
Model Number LF5637 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
According to the reporter, during hemicolectomy procedure, the device was plugged into the generator but it had jaw issues, it was d ifficult/impossible to close and difficult/impossible to open and the tissue or vessel could not be release.Another device was successfully used with this generator.There was no patient injury.
|
|
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 noted the device's jaw and knife blade was stuck due to eschar buildup.The build up was removed and the jaw resumed proper function.The knife blade was able to advance and retracted properly after it was cleared from the buildup.More frequent cleaning of the jaws could have prevented build up of eschar.It was reported that the device was plugged into the generator but it had jaw issues, it was difficult/impossible to close and difficult/impossible to open and the tissue or vessel could not be release.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: keep the instrument jaws clean.Build up of eschar may reduce sealing and/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
|
|
|