MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLER, SURGICAL

Model Number	EEA21
Medical Device Problem Codes	Device Slipped (1584); Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, during a radical resection of esophageal cancer procedure, when the stapler was activated, the device could not be completely closed and the staple burst out.The staple fell off and fell into the chest cavity.The surgeon then removed the lost staples one by one using an aspirator for suction.To complete the case, a new device was used.This resulted in prolonged surgery time and increased risk of infection.
Event or Problem Description
According to the reporter, during a radical resection of esophageal cancer procedure, when the stapler was activated, the device could not be completely closed and the staple burst out.The staple fell off and fell into the chest cavity.The surgeon then removed the lost staples one by one using an aspirator for suction.To complete the case, a new device was used.This resulted in prolonged surgery time of less than 30 minutes and increased risk of infection.
Additional Manufacturer Narrative
Additional information: b5, g3 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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21636684
• Report Number: 2647580-2025-00859
• Device Sequence Number: 18012512
• Product Code: GAG
• UDI-Device Identifier: 10884523004663
• UDI-Public: 10884523004663
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: EEA21
• Device Catalogue Number: EEA21
• Device Lot Number: P4A1027S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/19/2025
• Date Device Manufactured: 01/16/2024
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG