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

Model Number	EGIAUXL
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egiauxl,egiauxl endogia ultra univ xl stapler, (lot number: p4a0996) sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel, (lot number: n3c0810y) sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel, (lot number: n5j1450y) sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel, (lot number: n3c0810y) sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel, (lot number: n5j1450y) sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel, (lot number: n5j1450y) egia45amt, egia45amt egia 45 artic med thick sulu, (lot number: 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 sleeve gastrectomy, the handles reportedly broke and cracked.The surgeon attempted multiple reloads and went from purple to black on the antrum of the stomach, yet the surgeon could not fire through one area of the stomach; it was partially fired.After multiple attempts, the surgeon moved lateral and completed the sleeve with no issues.The surgeon oversewed the staple line at the area.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the instrument firing knobs were retracted.Functional testing found that during the firing cycle, a skip was audible in the firing stroke.An access hole was cut into the instrument body for visualization of the firing rack.Sheared teeth were visible on the firing rack.It was reported that the device did not fire completely and the handle was broken.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur in any of the following circumstances, firing over tissue that is beyond the recommended thickness range.Firing with an obstacle incorporated in the jaws.Attempting to fire a reload that is in interlock.In each circumstance, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly, and tissue may not be fully transected.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ ultra universal short, endo gia¿ ultra universal or endo gia¿ ultra universal xl stapler.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.When using the stapler more than once during a single surgical procedure, be sure to remove the empty endo gia¿ single use reload and load a new one.A safety interlock is provided that prevents an empty single use reload from being fired a second time.Do not attempt to override the safety interlock.Overriding the safety interlock will cause device malfunction.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: ENDO GIA ULTRA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 24372506
• Report Number: 2647580-2026-00410
• Device Sequence Number: 4837350
• Product Code: GDW
• UDI-Device Identifier: 10884523003550
• UDI-Public: (01)10884523003550(17)300831(10)P5J1186(20)04
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: P5J1186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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 Age: 43 YR
• Patient Sex: Male