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

Model Number	030423
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.10.Concomitant products: egia60axt, egia60axt egia60 artic extra thicksulu (lot#: n4f2143y), egiaustnd, egiaustnd endogia ultra univ std stap (lot#: p5b0841s).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 thoracoscopic left upper lobectomy, a manual handle with a reload was used for interlobar fissure detachment when the staple burst out, the staples lacked proper b-shaped formation and the staple line was incomplete, resulting in bleeding.After replacing the reload, the staple line remained incomplete after firing and additional bleeding occurred in the midsection.The surgical time was extended by 30 minutes or more due to these issues.Manual suturing was performed under laparoscopy to resolve the incomplete staple line and bleeding.
Additional Manufacturer Narrative
Correction: e1 (phone number).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
Additional information: d9, 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 loading unit was fully fired and the jaws were open.A malformed staple was stuck inside the jaws.It was reported that the staples lacked proper b-shaped formation, and the staple line was incomplete, resulting in bleeding.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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: do not use the endo gia¿ universal 4.8 mm staples on any tissue that compresses to less than 2.0 mm in thickness, on any tissue that cannot comfortably compress to 2.0 mm or on the aorta.Always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ universal stapler.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 a staple line buttressing material, follow the instructions provided by the manufacturer of the buttress material, as performance of the stapler may be affected when using buttress materials.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
• 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: 23093678
• Report Number: 2647580-2025-02862
• Device Sequence Number: 18594100
• Product Code: GDW
• UDI-Device Identifier: 10884523002980
• UDI-Public: (01)10884523002980(17)250831(10)P0J0477SY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 03/17/2026

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: 030423
• Device Catalogue Number: 030423
• Device Lot Number: P0J0477SY
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 03/16/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/19/2025; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 107 KG