|
Model Number EGIA60AVM |
Device Problem
Entrapment of Device (1212)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/17/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
D10 concomitant products: sigphandle, sig power sigphandle handle, unk-sigadapt, unknown signia egia adapter.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 laparoscopic pancreatectomy, after stapling the pancreas, the jaws did not open and locked on tissue.The surgeon used a retraction key to open the reload.There was no patient injury.
|
|
Event Description
|
According to the reporter, during a laparoscopic pancreatectomy, after charging the device, the jaws closed and remained locked.The surgeon used a retraction key to open the reload.There was no patient injury.
|
|
Manufacturer Narrative
|
Additional information: new information has been received on 02apr2024 pertaining to the event's event description, codes (rfr and fdd).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
|
|
|