MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030449
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a atypical laparoscopic pulmonary resection, the surgeon initially used the manual short handle, which worked for the first reload but did not fire with the second reload.Second manual short handle was used but did not fire with the second reload.Attempts to use another manual handle with the second reload but also failed to fire.Ultimately, a purple reload was used successfully.After the procedure, a nurse tested the devices, confirming that the second manual short handle and the manual handle worked properly with the purple reloads.Both handles and reload were replaced to resolve the issue.There was extended surgical time.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant product: egiaushort endogia ultra univ sht stap (lot#: p3d0228) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm (lot#: n2a0161y) egiaushort endogia ultra univ sht stap (lot#: p3d0228).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
Correction: b5, d10 concomitant product: egiaushort endogia ultra univ sht stap (lot#: p3d0228) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm (lot#: n2a0161y) egiaushort endogia ultra univ sht stap (lot#: p3d0228) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm (lot#: n2a0161y) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm (lot#: n2a0161y) egiaushort endogia ultra univ sht stap (lot#: unknown) 030449 endo giaii uni ins (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
It was reported that during an atypical laparoscopic pulmonary resection by thoracoscopy, when on parenchymal section, the surgeon initially used the manual short handle, which worked for the first reload but did not fire with the second reload.Second manual short handle was used but did not fire with the second reload.Attempts to use another manual handle with the second reload but also failed to fire.Ultimately, a purple reload was used successfully.After the procedure, a nurse tested the devices, confirming that the second manual short handle and the manual handle worked properly with the purple reloads.Both handles and reload were replaced to resolve the issue.There was extended surgical time.No patient complications have been reported as a result of this event.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 21714136
• Report Number: 2647580-2025-00963
• Device Sequence Number: 4655936
• Product Code: GDW
• UDI-Device Identifier: 10884523003505
• UDI-Public: 10884523003505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 030449
• Device Catalogue Number: 030449
• Device Lot Number: P3D0489
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 04/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11; SEE NOTE ON H11
• Patient Sex: Unknown