MAUDE Adverse Event Report: COVIDIEN SURGICAL GIA; STAPLER, SURGICAL

Model Number	GIA80MTS
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during hemicolectomy and ileocolic anastomosis, an incomplete staple line was noted.There was no continuity of staples in two segments, resulting in intestinal content leakage.The affected intestinal segment required manual resection and anastomosis.
Additional Manufacturer Narrative
D10: concomitant products: gia80mtc, cartridge gia80mtc medthk tristp (lot#:n4m1685uy), gia80mtc, cartridge gia80mtc medthk tristp (lot#:n4m1685uy).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
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but four photos were available for evaluation.Visual inspection noted that, in the first image, a staple line in tissue was observed and the staples appeared to have formed as expected.A pair of forceps was inserted into an open section of the tissue to the left of the staple line.In the second image, a staple line in tissue was observed and the staples appeared to have formed as expected.In the third and fourth images, reference and lot number information for two different devices was observed.It was reported that staple line content leakage occurred and that the staple line was incomplete.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: GIA
• Common Device Name: STAPLER, SURGICAL
• 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: 24512953
• Report Number: 1219930-2026-01470
• Device Sequence Number: 13360447
• Product Code: GAG
• UDI-Device Identifier: 10884521723450
• UDI-Public: (01)10884521723450(17)300630(10)N5G1889UY(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K221006
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: GIA80MTS
• Device Catalogue Number: GIA80MTS
• Device Lot Number: N5G1889UY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Female