MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEA2835
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Fever (1858); Obstruction/Occlusion (2422)
Date of Event	07/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a sigmoidectomy, when the surgeon fired the device for an end to end anastomosis, no staples deployed.Intestinal fluid and feces overflowed into the abdominal cavity.The patient's abdominal cavity had to be thoroughly washed and the rectum was sutured to make a colostomy.The patient had fever and partial intestinal obstruction.
Additional Manufacturer Narrative
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: b5, g3, h3, h6 correction: d4 (unique identifier (udi) #) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.Visual inspection noted the first photo showed a picture of the anvil post firing.The second photo showed the underside of the anvil with the donut attached.The mylar appeared to have been fully cut.Witness marks on the anvil staple pockets could not be observed from the photo.The third photo showed the handle.The staple cartridge was attached, but the angle of the photo did not allow observation of the staples/pushers.A video was also returned of the handle being placed on the table.No information from the video could be used to confirm the reported condition.It was reported that the staples did not deploy.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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.
Event or Problem Description
According to the reporter, during a sigmoidectomy procedure, when the surgeon fired the device for end-to-end anastomosis, no staples were deployed.Intestinal fluid and feces had overflowed into the abdominal cavity.The patient's abdominal cavity had to be thoroughly washed, and the rectum was sutured to make a colostomy.It was noted that the surgical time was extended by more than 30 minutes.Now the patient has fever and partial intestinal obstruction and the hospitalization has been extended.

• 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: 22801392
• Report Number: 2647580-2025-02502
• Device Sequence Number: 12712431
• Product Code: GAG
• UDI-Device Identifier: 10884523005547
• UDI-Public: (01)10884523005547(17)280131(10)P3B0085
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K221003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EEA2835
• Device Catalogue Number: EEA2835
• Device Lot Number: P3B0085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 66 KG