MAUDE Adverse Event Report: COVIDIEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030414
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 030414, 030414 endo gia uni 60 3.5 dlu x6, (lot # p2h0312); unknown endo gi, unknown endo gia instrument, (lot # unknown).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, in a laparoscopic gastrectomy, grasping with the two reloads were difficult.The reloads also did not rotate when mounted on the handle.The staple line of the two reloads were bleeding.The staple lines also did not hold and leaked.A leak test came out positive.
Additional Manufacturer Narrative
Additional information: b5, g3 correction: h6 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, in a laparoscopic gastrectomy, grasping with the two reloads were difficult.The reloads also did not rotate when mounted on the handle.The staple line of the two reloads were bleeding.The staple lines also did not hold and leaked.A leak test came out positive.Another reload was used to complete the case.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 22535314
• Report Number: 2647580-2025-02165
• Device Sequence Number: 15325281
• Product Code: GDW
• UDI-Device Identifier: 10884523002928
• UDI-Public: 10884523002928
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 030414
• Device Catalogue Number: 030414
• Device Lot Number: P2H0312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 08/16/2022
• 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: 41 YR
• Patient Sex: Male