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

Model Number	EGIA60AVM
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction

• 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 CT 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50144950
• Report Number: 1219930-2026-04890
• Device Sequence Number: 18421889
• Product Code: GDW
• UDI-Device Identifier: 10884523003222
• UDI-Public: (01)10884523003222(17)300930(10)P5K1049(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: EGIA60AVM
• Device Catalogue Number: EGIA60AVM
• Device Lot Number: P5K1049
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 10/09/2025
• 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
• Patient Age: 32 YR
• Patient Sex: Female