MAUDE Adverse Event Report: Covidien Endo GIA; STAPLE, IMPLANTABLE

Model Number	EGIA45AMT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/19/2026
Type of Reportable Event	Serious Injury

• Brand Name: Endo GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer (Section G): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50599844
• Report Number: 2647580-2026-02621
• Device Sequence Number: 13130560
• Product Code: GDW
• UDI-Device Identifier: 10884523003154
• UDI-Public: (01)10884523003154(17)300831(10)P5J1020(20)07
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: EGIA45AMT
• Device Catalogue Number: EGIA45AMT
• Device Lot Number: P5J1020
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 09/12/2025
• 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: Hospitalization
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 445 LB