MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEA2535
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Form Staple (2579)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the open right hemicolectomy, when using the linear stapler to detach the right colon, excessive resistance was encountered, making firing impossible.The firing proceeded normally after replacing it with a new linear stapler. subsequently, when using a brand-new circular stapler to anastomose the transverse colon and ileum, "b" shaped malformed staples were observed.It was also noted that the anvil did not tilt after firing.Sutures were then used for reinforcement afterwards.
Additional Manufacturer Narrative
D10 concomitant product: gia8038s, gia8038s gia 80-3.8sgl use reload stap (lot # p4b0802s).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.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the malformed staples were observed and the anvil did not tilt after firing.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: EEA
• Common Device Name: STAPLER, SURGICAL
• 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: 22693091
• Report Number: 2647580-2025-02434
• Device Sequence Number: 20899999
• Product Code: GAG
• UDI-Device Identifier: 10884523004748
• UDI-Public: (01)10884523004748(17)290630(10)P4G1274S(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/26/2025

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: EEA2535
• Device Catalogue Number: EEA2535
• Device Lot Number: P4G1274S
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 67 KG