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

Model Number	030459
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a thoracoscopic wedge resection of the lung, at the beginning, while using the first handle and reload, the staples were poorly formed and it burst out.A second reload was used with the first handle, and during firing, the stapler pushed halfway and could not continue to push.The surgeon continued to push, and a loud, abnormal sound was heard.A second handle and third reload were used; the stapler pushed halfway and could not continue to push; the resistance was very large; and an abnormal sound was heard, but the surgeon was not sure if it was damaged.A fourth reload was used with the second handle, and during firing, it could not be pushed, and the handle was damaged.A purple reload was used with the second handle, and during firing, it could not be pushed, and the handle was damaged.The surgeon replaced the handle and used the same purple reload, but during firing, it pushed halfway, and it could not continue to push.Surgical time was extended by about 30 minutes.The surgeon manually sutured the tissue to resolve the issue.The surgeon used another brand of stapler to complete the case.
Additional Manufacturer Narrative
D10 concomitant product: egiaustnd, egiaustnd endogia ultra univ std stap (lot#p4l0660s); egiaustnd, egiaustnd endogia ultra univ std stap (lot#p4l0660s); egiaustnd, egiaustnd endogia ultra univ std stap (lot#p4l0660s); 030459, 030459 endo gia r/or 60 4.8mm (lot#t1m168x); 030459, 030459 endo gia r/or 60 4.8mm (lot#t1m168x); egia60amt, egia60amt egia 60 artic med thick sulu (lot#p5a1045s) 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.A video was also provided.Visual inspection noted the loading unit was partially fired, the anvil was bowed and the clamping mechanism was deformed.Functionally, the loading unit was loaded into a representative instrument.The interlock was overridden, the loading unit was cycled without hesitation or binding and was applied to test media.All remaining staples were placed and test media was cleanly transected.The interlock was tested and found to function properly.It was reported that the staples were poorly formed and it burst out.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In any of these circumstances, 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: select a loading unit with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.Always include the combined thickness of the tissue and of any staple line reinforcement material in use when choosing the proper staple cartridge.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): SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): 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: 22566468
• Report Number: 1219930-2025-03153
• Device Sequence Number: 3811062
• Product Code: GDW
• UDI-Device Identifier: 10884523002904
• UDI-Public: (01)10884523002904(17)261229(10)T1M168X(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
• Report Date (Section B): 09/18/2025

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: 030459
• Device Catalogue Number: 030459
• Device Lot Number: T1M168X
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• 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: PLEASE SEE NOTE ON H11
• Patient Age: 66 YR
• Patient Sex: Male