|
Model Number EEAXL28 |
Device Problems
Detachment of Device or Device Component (2907); Insufficient Information (3190); Noise, Audible (3273)
|
Patient Problems
Failure to Anastomose (1028); Tissue Breakdown (2681); Insufficient Information (4580)
|
Event Date 01/16/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
D10 concomitant product: eeaxl2835, eeaxl2835 eea xl28 mm-3.5 sgl use stap (lot#p3b0273).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.
|
|
Event Description
|
According to the reporter, during a open colosotomy reversal, when creating the anastomosis of the colon, the surgeon squeezed the device once to fire the device.Afterwards, when the surgeon decided to do a second squeeze, there was a loud crack and the top of the tilt top anvil broke off and fell into the patient's cavity and was retrieved by the surgeon from the anal cavity by hand.It was also reported that the anastomosis had a leak.Another stapler was used and it had the same issue.
|
|
Event Description
|
According to the reporter, during a open colosotomy reversal, when creating the anastomosis of the colon, the surgeon squeezed the device once to fire the device.Afterwards, when the surgeon decided to do a second squeeze, there was a loud crack and the top of the tilt top anvil broke off and fell into the patient's cavity and was retrieved by the surgeon from the anal cavity by hand.It was also reported that the anastomosis had a leak.
|
|
Manufacturer Narrative
|
Additional information: b5, g3, h6 new information has been received pertaining to the event (device is an unauthorized return base on the e-mail provided by sales rep.) 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 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
|
|
|