MAUDE Adverse Event Report: Covidien Surgical GIA; STAPLER, SURGICAL

Model Number	GIA80MTC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure, the interlock broke.The procedure initially began as a diagnostic surgery and was converted to an exploratory laparotomy with resection, omentectomy, left hemicolectomy, proximal and distal bowel closure, and loop ileostomy.It was noted that the procedure time was extended by approximately 20 minutes.The device issue was addressed by performing a power-on reset and using another reload from a different lot.The patient had an extended hospitalization and was admitted to the intensive care unit; however, the icu admission was not related to the reported blade break.The icu admission was due to the conversion of the procedure and the patient's underlying pathology, which resulted in a more complex surgical intervention.Based on the available information, the patient's clinical condition at the time of icu admission was considered guarded; however, this was attributable to the complexity of the surgical procedure rather than the reported device event.The prolonged hospitalization was also not directly associated with the reported device event.
Additional Manufacturer Narrative
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--439 ; +1(800)646-4633
• MDR Report Key: 50065722
• Report Number: 1219930-2026-04696
• Device Sequence Number: 10217111
• Product Code: GAG
• UDI-Device Identifier: 10884521723528
• UDI-Public: (01)10884521723528(17)270430(10)N2E0601UY(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: GIA80MTC
• Device Catalogue Number: GIA80MTC
• Device Lot Number: N2E0601UY
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2026
• Supplement Date Received by Manufacturer: Not provided; 09/22/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/19/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female