MAUDE Adverse Event Report: COVIDIEN GIA; STAPLER, SURGICAL

Model Number	GIA8048L
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: gia8048s, gia8048s gia 80-4.8sgl use reload stap, (lot # p4g1088) gia8048l, gia8048l gia 80-4.8sgl use loadingunit, (lot # p4d0840) gia8048l, gia8048l gia 80-4.8sgl use loadingunit, (lot # p4d0840).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 resection and right ileocolonic anastomosis on occlusion, when using the second refill, the stapling line did not go all the way to the end of the clamp.An additional refill was given after rinsing the clamp and again the stapling line was incomplete.With a fourth refill, the surgeon wanted to change sides to finish his cut and anastomosis (from the opposite end of the cut) and the operation then went well.

• Brand Name: GIA
• 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: 25168187
• Report Number: 2647580-2026-01417
• Device Sequence Number: 18692020
• Product Code: GAG
• UDI-Device Identifier: 10884523007275
• UDI-Public: (01)10884523007275(17)290331(10)P4D0840
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221013
• 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
• Report Date (Section B): 05/14/2026

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: GIA8048L
• Device Catalogue Number: GIA8048L
• Device Lot Number: P4D0840
• 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: 05/05/2026
• Initial Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 04/03/2024
• 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
• Patient Sex: Unknown