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

Model Number	EGIA60CTAMT
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant medical products: egia60ctamt, egia60ctamt egia60 curved medthicksulu (lot n4b2176y) 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
According to the reporter, during a laparoscopic subtotal colectomy procedure, in colon anastomosis in small pelvic spaces, on two reloads, some of the staples failed to form properly.Visually, some of the b-shaped staples were still on the proximal part of the reload.To resolve the issue, clips were used.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: d4 (unique identifier (udi) #) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted four images of the reloads were received.The jaws of the reloads were open.Staple pushers were up distally in all images.Two reloads were visible in another photo.No staples could be seen protruding from the staple cartridge of the upper reload.Staples were visible in the proximal end of the staple cartridge of the other reloads in the returned images.No abnormal staple formation could be seen.Visual inspection of the returned device noted that the reload was fully fired.Functionally, the reload was loaded into a representative instrument.The interlock was overridden.The reload was cycled without hesitation or binding and was applied to test media.The test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that there was poor staple formation and the staple line was incomplete.The reported issues were not confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: thick tissue.Visually, the clamping mechanism was deformed.The product analysis noted evidence that the device was not used as intended.This issue may occur under the following conditions.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: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.Always inspect the tissue thickness and select an appropriate staple size prior to application of the 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.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: 22040624
• Report Number: 1219930-2025-02203
• Device Sequence Number: 18338138
• Product Code: GDW
• UDI-Device Identifier: 10884523003246
• UDI-Public: (01)10884523003246(17)290131(10)N4B2176Y(20)02
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: EGIA60CTAMT
• Device Catalogue Number: EGIA60CTAMT
• Device Lot Number: N4B2176Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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 Age: 26 YR
• Patient Sex: Female