|
Model Number 134051 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, on an open coronary artery bypass graft (cabg), while ligating vessels, the clips were not forming and falling off the vessels.Multiple units were used with the same issue.Another device from another lot was used to complete the case.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, on an open coronary artery bypass graft (cabg), while ligating vessels, the clips were not forming and falling off the vessels.At least three units were used with the same issue.Another device from another lot was used to complete the case.There was no patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The devices were available for evaluation.Visual inspection noted that the ratchet was engaged, the device was incompletely cycled and the distal end of the channel cover was cracked.It was reported that the clips did not close completely, malformed, and did not hold tightly to the vessel and detached.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues can occur if an attempt was made to fire the instrument with the ratchet system engaged and forcing the handles open prior to completing the firing cycle resulting in multiple indexing of the clips.These can also occur if the distal end of the device was subjected to excessive manipulation during application.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: with the ratchet in the off position, the handles must be compressed together firmly as far as they will go.As the handles are compressed the clip is held firmly by the jaw and closed around the vessel or structure.With the ratchet in the on position the handles can be released at anytime before the clip is closed around the vessel or structure, but the final stroke insures complete clip formation.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
|
|
|