MAUDE Adverse Event Report: COVIDIEN TA; STAPLER, SURGICAL

Model Number	TA6035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 12 days after surgery on a laparoscopic right hemicolectomy, an anastomotic leakage occurred.It was noted that ten reloads were used and had the same issue.
Additional Manufacturer Narrative
D10 concomitant products: egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4m1410y), egia60avm, egia60avm egia 60 artic vasc med sulu (lot#: n4j1689y).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.
Additional Manufacturer Narrative
Correction: b1, b2, h1 additional information: a3a correction has been reviewed pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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: TA
• Common Device Name: STAPLER, SURGICAL
• 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: 22584927
• Report Number: 2647580-2025-02291
• Device Sequence Number: 4565043
• Product Code: GAG
• UDI-Device Identifier: 10884521043213
• UDI-Public: (01)10884521043213(17)290531(10)P4F0898(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K231491
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TA6035S
• Device Catalogue Number: TA6035S
• Device Lot Number: P4F0898
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/31/2025
• Date Device Manufactured: 06/13/2024
• 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: Other
• Patient Sex: Female