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

Model Number	GIA80MTC
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: gia80mts, stapler gia80mts med thick tristp (lot n5f1513uy).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 during a laparoscopic right hemicolectomy, the stapler was employed for bowel transection.The device fired all the way, but upon inspection of the staple line, the surgeon identified that the first two staple rows contained no visible staples, although the tissue had been transected.Mild bleeding was noted at the portion of the staple line where the staples had not deployed, and suturing was performed directly over the area of absent staples to achieve hemostasis.During a subsequent firing with a 2nd cartridge, mild bleeding was again observed at the staple line, which was managed by an additional stapler firing to reinforce the staple line and achieve hemostasis.No further bleeding was observed following these interventions.
Additional Manufacturer Narrative
Correction: h6 (fdd a050704 removed) 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: 23854921
• Report Number: 1219930-2025-05940
• Device Sequence Number: 5030174
• Product Code: GAG
• UDI-Device Identifier: 10884521723528
• UDI-Public: (01)10884521723528(17)291031(10)N4L1607UY(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: GIA80MTC
• Device Catalogue Number: GIA80MTC
• Device Lot Number: N4L1607UY
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 11/19/2024
• 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.
• Patient Sex: Female