|
Model Number 176630 |
Device Problems
Failure to Fire (2610); Mechanics Altered (2984)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2024 |
Event Type
malfunction
|
Event Description
|
According to the reporter, in a laparoscopic appendectomy, there was an issue experienced with the loading or firing of the clips.The surgeon was unable to fire the clip during the procedure.The surgeon sutured instead.There was no patient injury.
|
|
Manufacturer Narrative
|
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.The visual inspection of the returned product noted the instrument was partially applied.The clip counter was no longer active.The dink marks that hold the jaws in place were acceptable.Functionally, the instrument was cycled, and the clip was loaded into the jaws.The jaws and tissue stop to moved forward out of the shaft.The jaws did not close during the firing cycle.It was reported that the clips did not load properly and the clip applier did not fire.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur when the jaws were closed and a twisting motion was applied to the device spinning the shaft around the jaws causing damage leading to the reported condition.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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
|
|
|