MAUDE Adverse Event Report: COVIDIEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA60AVM
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	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: b5 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 robot-assisted laparoscopic small gastric bypass, the device was slowly pulsed fired with 5-10 pauses in between.When the device reached the end of firing, the surgeon paused for 30 seconds to make sure that the tissue was fully relaxed before retracting the blade.The bleeding appeared 15 minutes later through out the entire staple line for the gastric pouch.A total of five reloads were used.All clips from the clip applier were used to stop the bleeding.It was noted that the tissue felt normal when firing.
Additional Manufacturer Narrative
D10.Concomitant products: sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm (lot n6a1409y); egia60avm, egia60avm egia 60 artic vasc med sulu (lot p5m0488); egia60amt, egia60amt egia 60 artic med thick sulu (lot p5l1186); egia60amt, egia60amt egia 60 artic med thick sulu (lot p5l0835); egia45avm, egia45avm egia 45 artic vasc med sulu (lot unknown).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 robot-assisted laparoscopic small gastric bypass, the device was slowly pulsed fired with 5-10 pauses in between.When the device reached the end of firing, the surgeon paused for 30 seconds to make sure that the tissue was fully relaxed before retracting the blade.The bleeding appeared 15 minutes later through out the entire staple line for the gastric pouch.A total of five reloads were used.All clips from the clip applier were used to stop the bleeding.It was noted that the tissue felt normal when firing.Pli 60: product received without accompanying information.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25073838
• Report Number: 2647580-2026-01302
• Device Sequence Number: 21504301
• Product Code: GDW
• UDI-Device Identifier: 10884523003222
• UDI-Public: (01)10884523003222(17)300930(10)P5K1280(20)07
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: EGIA60AVM
• Device Catalogue Number: EGIA60AVM
• Device Lot Number: P5K1280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 10/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 158 KG