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

Model Number	EGIAUXL
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: d3 (mfr name, street 1, mfr city, mfr region, postal code) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was attached to the returned reload.The firing knobs were advanced and the articulation lever was in neutral position.Functionally, the instrument knobs were retracted with difficulty.The reload was removed manually.It was reported that the instrument locked on tissue.The reported issue was confirmed.The most likely cause was traced to the returned attached reload.It was also reported that the jaws will not open completely.The reported issue 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.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
D10.Concomitant products: egia45avm, egia45avm egia 45 artic vasc med sulu (lot 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
It was reported that during a laparoscopic whipple procedure or liver resection, while transecting the liver, the device fired completely, but there was an incomplete staple line at the distal end.Additionally, the jaws were stuck in the middle when it was attempted to open.The surgeon had to force open the jaws with difficulty.To complete the case, a new handle was used for resection and restaple.

• Brand Name: ENDO GIA ULTRA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce,pr CT 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce,pr CT 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24551398
• Report Number: 1219930-2026-01539
• Device Sequence Number: 21178578
• Product Code: GDW
• UDI-Device Identifier: 10884523003550
• UDI-Public: (01)10884523003550(17)300831(10)P5J0927(20)04
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: EGIAUXL
• Device Catalogue Number: EGIAUXL
• Device Lot Number: P5J0927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Male