|
Model Number 179301 |
Device Problems
Detachment of Device or Device Component (2907); Packaging Problem (3007)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 03/30/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter post operative a complete macroscopic exeresis of a cystic lump of the left posterior mediastinum using thoracoscopy, after 4 days when a exploratory left thoracotomy for mediastinitis was being performed on the same patient a small plastic part was fortuitously found and retrieved, which looks like a part of the single use port in the procedure performed 4 days earlier.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Additionally photographs of the device were also received.A visual ins pection of the returned photos noted: the first image depicts a blue/green piece of plastic under a clear cup.The second image depicts the blue/green piece of plastic turned over under a clear plastic cup.A visual inspection of the returned product noted: that a small piece of green plastic was received in a sample jar.The condition in which the device was received precludes functional testing.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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, on (b)(6) 2020 the patient was operated for complete macroscopic removal of a cystic lump of the left posterior mediastinum using thoracoscopy, after 4 days when a exploratory left thoracotomy for mediastinitis was being performed on the same patient who was found to have a cystic mass of the left posterior mediastinum, a small plastic piece was accidentally found in the subcutaneous tissue and retrieved, based on its colour, it looks like a part of the single use port in the procedure performed 4 days earlier.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|