|
Model Number EEA28 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
|
Patient Problem
Tissue Breakdown (2681)
|
Event Date 11/20/2023 |
Event Type
malfunction
|
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 total gastrectomy, to remove the rectosigmoid, when the surgeon closed the until the green line appear, the surgeon waited about 20 seconds and performed the stapling, then a 4 half turn was to angle was made.A difficulty was felt when removing the staple, and due to a lot of handling the anvil released from the staple.An anuscope was used to remove the anvil and it was necessary to perform another anastomosis.The surgical time was increased by an hour due to the issue.
|
|
Manufacturer Narrative
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was fully applied.Further inspection noted that the green bar was visible in the indicator window and the safety feature was engaged.The staple guide was observed to be attached to the instrument with no damage to the staple guide.After actuating the handle, the pusher fingers appeared to be intact and inspection under the microscope displayed nicks on the knife blade.The anvil of the instrument was observed to be tilted and separated from the instrument.Further inspection of the anvil cutting ring showed deep traces of knife impression and the ring was received completely severed.One of the retainer legs of the anvil was observed to be bent.Functionally, due to the observed retainer leg damage of the clinical anvil, an rpa representative anvil was attached to the center rod without difficulty prior to firing the instrument.The wing nut and safety functioned properly upon rotating the twist knob.The green bar was visible within the indicator window when the twist knob was fully closed.The instrument was applied to the appropriate test media producing acceptable results.Pusher-fingers and knife advance when the handle was squeezed and the knife cut the media cleanly and completely, despite the noted knife blade damage.The device also produced all audible, tactile and visual indicators during the functional testing.It was reported that the device was difficult to remove from the cavity and the anvil disengaged.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the anvil is manipulated with excessive force during the attachment/detachment to/from the instrument the manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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
|
|
|