MAUDE Adverse Event Report: COVIDIEN SURGICAL ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA45AMT
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Misfire (2532)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigadaptxl, sig power sigadaptxl linear xl adapter, (serial # (b)(6) sigphandle, sig power sigphandle handle, (serial # unknown) 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 procedure, the firing was interrupted at the beginning, it was also difficult to retract the knife blade and the device was locked on tissue.Additionally, at the onset of the cartridge firing sequence, when the error occurred, the following information was displayed on the screen: within the powered stapler block, the status appeared in green; within the adapter block, it appeared in black with a green border; and within the cartridge block, a cartridge icon was displayed alongside a yellow triangle containing a symbol indicating that the tissue had dried out, thereby necessitating manual suturing using the device.The surgeon was compelled to perform a tissue resection on the bronchus, larger than necessary in order to remove the load and adapter, which led to extended surgical time of more than three hours.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 25403170
• Report Number: 1219930-2026-03544
• Device Sequence Number: 10327200
• Product Code: GDW
• UDI-Device Identifier: 10884523003154
• UDI-Public: (01)10884523003154(17)310131(10)N6B1065Y(20)04
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111825
• 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): 06/04/2026

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: EGIA45AMT
• Device Catalogue Number: EGIA45AMT
• Device Lot Number: N6B1065Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/04/2026
• Date Device Manufactured: 02/05/2026
• 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: Male