MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA30AVM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egia30avm, egia30avm egia30 artic vascual medsulu (lot#:n3d0017y), egia60axt, egia60axt egia60 artic extra thicksulu (lot#:n3e0091y), egia60axt, egia60axt egia60 artic extra thicksulu (lot#:n3e0091y) 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 or Problem Description
According to the reporter during a procedure, after firing, there was staple line bleeding on the four reloads.It was noted that the surgical time was extended.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.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 or Problem Description
According to the reporter, during a gastric bypass, after firing, there was staple line bleeding on the four reloads.It was noted that the surgical time was extended for 45 minutes.
Event or Problem Description
According to the reporter, during a gastric bypass, after firing, there was staple line bleeding on the four reloads.It was noted that the surgical time was extended for 45 minutes.Medtronic's initial evaluation of the incident device found that the instrument consistent with application over an obstruction.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the interlock was overridden, the reload was cycled without hesitation or binding and was applied to test media.The reload interlock was tested and found to function properly.It was reported that the staple line was bleeding.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: when positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20380169
• Report Number: 1219930-2024-04667
• Device Sequence Number: 9628204
• Product Code: GDW
• UDI-Device Identifier: 10884523003123
• UDI-Public: 10884523003123
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EGIA30AVM
• Device Catalogue Number: EGIA30AVM
• Device Lot Number: N3D0017Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 12/09/2024
• Initial Report FDA Received Date: 10/06/2024
• Supplement Report FDA Received Date: 10/09/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown