MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA45AXT
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Retraction Problem (1536)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a robotic low anterior resection, the device failed, prompting the surgical team to switch to the powered stapler with a black reload cartridge.While using the powered stapler, the reload malfunctioned, ceasing to function and becoming unresponsive during an attempt to retract the knife blade.Despite following the troubleshooting guide and attempting manual retraction, the reload remained locked on the tissue.The articulation joint of the reload was later found to be broken.They had to use another instrument to separate the reload from the tissue.The surgery was completed using different stapler to resect and re-staple, and suturing was done as a staple line reinforcement.
Additional Manufacturer Narrative
D10 concomitant product: sigphandle, sig power sigphandle handle, (serial# unknown) sigadaptstnd, sig power sigadaptstnd linear adapter, (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.
Additional Manufacturer Narrative
Additional information d9, g3, h3, h6.Correction: e1 (phone number) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.A visual inspection of the returned photos noted that in the first returned photo, the i-beam was seen to be advanced and the jaws of the reload were clamped.The reload was noted to be articulated to the left and the non-articulation side blowout plate was fractured proximally.The laminates were herniated out of the articulation joint.The second returned photo contained a view of the reload being used in surgery wherein again, the damage to the blowout plate and laminates was noted.Visual inspection noted that the reload was partially fired and the reload adapter was broken.It was reported that during the robotic low anterior resection, the device failed, prompting the surgical team to switch to the powered stapler with a black reload cartridge.While using the powered stapler, the reload malfunctioned, ceasing to function and becoming unresponsive during an attempt to retract the knife blade.Despite following the troubleshooting guide and attempting manual retraction, the reload remained locked on the tissue.The articulation joint of the reload was later found to be broken.The reported issues were confirmed.The most likely cause could not be established from the information available.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22119856
• Report Number: 1219930-2025-02360
• Device Sequence Number: 4251709
• Product Code: GDW
• UDI-Device Identifier: 10884523003185
• UDI-Public: 10884523003185
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/14/2025

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: EGIA45AXT
• Device Catalogue Number: EGIA45AXT
• Device Lot Number: N4J1454Y
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Patient Sex: Unknown