MAUDE Adverse Event Report: COVIDIEN SURGICAL TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	UNKNOWN EGIA SU
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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egiauxl, egiauxl endogia ultra univ xl stapler, (lot # p5b0744) egia45avm, egia45avm egia 45 artic vasc med sulu, (lot # n5g2082y) egia60avm, egia60avm egia 60 artic vasc med sulu, (lot # n5j1630y) egia45avm, egia45avm egia 45 artic vasc med sulu, (lot # n5k1479y) egia60avm, egia60avm egia 60 artic vasc med sulu, (lot # n5h1419y) 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
It was reported that on post operative laparoscopic gastric bypass, a manual stapler and multiple reloads were used after three competitive staplers failed to staple over the tissue.The manual stapler and reloads were able to staple the tissue however the surgeon said that there was oozing/bleeding of staple line for the four reloads.The surgeon had to put a drain in the patient.The surgical time was extended by less than 30 mins as the surgeon needed time to control the bleeding surgically.The surgeon had to give intra-operative tranexamic acid and stop post-operative pharmacological vte prophylaxis to avoid more bleeding.
Additional Manufacturer Narrative
Additional information: b5, d4 (model #, catalog #, lot # removed), g3 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
It was reported that on post operative laparoscopic gastric bypass, a manual stapler and a total of five reloads were used after three competitive staplers failed to staple over the tissue.The manual stapler and reloads were able to staple the tissue however the surgeon said that there was oozing/bleeding of staple line for the four reloads.The surgeon had to put a drain in the patient.Thesurgical time was extended by less than 30 mins as the surgeon needed time to control the bleeding surgically.The surgeon had to give intra-operative tranexamic acid and stop post-operative pharmacological venous thromboembolism prophylaxis to avoid more bleeding.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23892689
• Report Number: 1219930-2025-06051
• Device Sequence Number: 17297969
• Product Code: GDW
• UDI-Device Identifier: 10884521543669
• UDI-Public: (01)10884521543669(17)300731(10)N5H1506Y(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 01/05/2026

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: UNKNOWN EGIA SU
• Device Catalogue Number: UNKNOWN EGIA SU
• Device Lot Number: N5H1506Y
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 08/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female