|
Model Number LPG1612 |
Device Problems
Product Quality Problem (1506); Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/27/2022 |
Event Type
malfunction
|
Event Description
|
According to the reporter, during a robotic laparoscopic ventral hernia repair, in pre-implantation stage, the device was hydrated and inserted.When the surgeon started working, the mesh was damage, it appeared to have a ¼" x 5 " melted.It was disformed, fused together and the device was removed.To resolve the issue, a new device was used.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.
|
|
Event Description
|
According to the reporter, during a robotic laparoscopic ventral hernia repair, in pre-implantation stage, the device was hydrated and inserted.When the surgeon started working, there was a discoloration in the middle of the mesh.The warped area were 1/4" x 5" perpendicular to the edges of the mesh, it was disformed, fused together.The device was removed.To resolve the issue, a new device was used.There was no patient injury.
|
|
Manufacturer Narrative
|
This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.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.
|
|
Search Alerts/Recalls
|
|
|